Spreadsheet: 0c00ea37-7c4f-4f6c-af7a-361ea94afb71
Sheet: Sheet1

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TMF Reference Model |  |  |  |  |  |  | Version 2.0 | 2012-06-25 00:00:00 |  |  |  | Sponsor Files - X: applicable; NO - Not applicable Investigator Site [NAME]: artifact specific for one site; XG: general artifact for all sites; NO: not for ISF; NO-CS: generally not for ISF apart from for limited countries
 |  |  |  |  |  |  |  |  |  |  |  | TMF Artifacts (Non-device) |  | TMF Artifacts (Device) |  | Investigator [NAME] Artifacts M: mandatory, D: dependent upon the type of study, R: recommended | Process [NAME] |  | Used to define paper TMF format and electronic metadata |  |  | Suggested Columns for Implementing the TMF Reference Model
TMF Zone |  | Section |  | Artifact name |  | Alternate names | Definition / Purpose | Core or Recommended for inclusion | ICH Code | Artifact name in v1.0 EDM Reference Model | Unique ID Number | Sponsor Document | Investigator Document | Sponsor Document | Investigator Document |  | Process Number | Process Name | Trial Level Document | Country/ Region Level Document | Site Level Document | Current Artifact Name | Artifact Owner | Artifact Location | Wet Ink Signature | SOP Reference | Translation Required | Dating Convention | [NAME]
01 | Trial Management | 01.01 | Trial Oversight | 01.01.01 | Trial Master File Plan | Records Management Plan File plan Filing instructions Filing and archive plan | To document how records for the trial will be managed and stored during and after the trial, including procedure and documentation for archiving and destruction. To include TMF filing structure to be used. | Recommended | 5.5.7 |  | 001 | X | NO | X | NO | R | 12 | Develop Trial Management Strategy | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.02 | Trial Management Plan | Project Management Plan | To identify overall strategy for timelines, management and conduct of the trial and typically makes reference to other artifacts. | Recommended | 2.2 |  | 002 | X | NO | X | NO | R | 12 | Develop Trial Management Strategy | X | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.03 | Quality Plan |  | To outline the operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.  Relevant parts may include but not be limited to a plan written for internal oversight of study quality management, an audit plan, data verification steps; also includes escalation in the event of a quality issue being identified and all corrective and preventative actions determined. | Recommended | 5.1 |  | 003 | X | NO | X | NO | R | 12 | Develop Trial Management Strategy | X | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.04 | List of SOPs Current During Trial |  | To document which standard operating procedures (SOPs) and which versions were in effect for the duration of the trial, and trial-specific procedures created for the trial. To include [NAME] and third party SOPs. This artifact does not include the SOPs themselves | Core | 5.1.1 |  | 004 | X | NO | X | NO | M | 12 | Develop Trial Management Strategy | X | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.05 | Operational Procedure Manual | Study Reference Manual Work Instruction | To describe trial-related processes not covered by formal standard operating procedures. Includes manuals given to sites for ISFs and vendor study-specific manuals | Recommended | 5.1.1 |  | 005 | X | XG | X | XG | R | 12 | Develop Trial Management Strategy | X | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.06 | Recruitment Plan |  | To document the planned subject enrolment/recruitment goals during the trial, including contingency plans. | Recommended | 5.6 |  | 006 | X | NO | X | NO | R | 12 | Develop Trial Management Strategy | X | X | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.07 | Communication Plan |  | To document communication strategy and plans between trial stakeholders, including communication escalation procedure/steps. | Recommended |  |  | 007 | X | NO | X | NO | R | 12 | Develop Trial Management Strategy | X | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.08 | Monitoring Plan |  | To describe how monitoring will be implemented during the trial, including strategy for source data verification. | Core | 5.18.3 |  | 008 | X | NO | X | NO | M | 12 | Develop Trial Management Strategy | X | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.09 | Medical Monitoring Plan |  | To describe how medical surveillance of trial subjects will be assured during the trial. | Core | 5.16 |  | 009 | X | NO | X | NO | M | 12 | Develop Trial Management Strategy | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.10 | Publication Policy |  | To describe the policy for publishing the trial results if publication policy is not captured within the protocol. | Recommended | 6.15 |  | 010 | X | NO | X | NO | R | 12 | Develop Trial Management Strategy | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.11 | Debarment Statement |  | To certify whether the applicant, or any of its principals, is currently debarred, suspended, proposed for debarment, or declared ineligible to receive federal awards; whether within the past three years the applicant, or any of its principals, has been convicted of or had a civil judgment rendered against it for, or been indicted for, commission of fraud or certain criminal offenses; and whether the applicant has had any federal award terminated for cause or default in the past three years. Often part of the site qualification process. | Recommended |  | Debarment Certification | 011 | X | NO | X | NO | R | 16 | Set up site(s) | X |  | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.12 | Trial Status Report |  | Routine trial status progress report generated by the sponsor or 3rd Party and distributed to trial stakeholders. | Recommended | 5.18.4 (g) |  | 012 | X | NO | X | NO | R | 21 | Manage Project / Report on Progress | X | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.13 | Investigator Newsletter |  | To inform investigative staff of  common implementation issues and of the progress of the trial. | Recommended |  |  | 013 | X | XG | X | XG | R | 21 | Manage Project / Report on Progress | X | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.14 | Audit Certificate |  | To document that an audit was performed. (Does not contain the audit report.) | Core | 8.4.4 |  | 014 | X | NO | X | NO | D | 27 | [NAME]) | X | X | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.15 | Filenote Master List | Note to File Master List | To provide a consolidated list/index of file notes generated during the trial. | Recommended |  |  | 015 | X | NO | X | NO | R | 21 | Manage Project / Report on Progress | X | X | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.16 | Risk Management Plan | Risk Assessment | A document identifying the potential hazards associated with the trial, including an assessment of the likelihood of those hazards occurring and resulting in harm.  The Risk Management Plan should include the risks to participant safety in relation to the IMP and all other risks related to the design and methods of the trial, including risks to participant safety and rights, as well as reliability of results. | Recommended |  |  | 236 | X | NO | X | NO | R | 12 | Develop Trial Management Strategy | X
01 | Trial Management | 01.01 | Trial Oversight | 01.01.17 | Vendor Management Plan |  | To document overall management strategy for vendors used to conduct trial-related activities. May include assignment of responsibilities for vendor oversight, performance indicators, monitoring activities and schedules, issue escalation and resolution process, technology and documentation transfer, and business continuity plan. | Recommended |  |  | 237 | X | NO | X | NO | R | 8 | Secure Resources / Vendors | X
01 | Trial Management | 01.02 | Trial Team | 01.02.01 | Trial Team Details | Trial Team Roles and Responsibilities Trial Team Members List Team Structure Team Roster Trial Team Log | To define trial roles, contact details and structure of the trial team - both Sponsor and third parties; may include organogram; optionally this may include full and initials-only signature of all team members. May include role-to-role transition documents and/or team joining/leaving dates. | Core | 2.8 5.7 |  | 016 | X | NO | X | NO | M | 7 | Secure Resources / People | X | X
01 | Trial Management | 01.02 | Trial Team | 01.02.02 | Trial Team Curriculum Vitae |  | To document qualifications and eligibility of Trial Team Members, including sponsor and 3rd Party. May be indication of where these are filed | Core | 2.8 |  | 017 | X | NO | X | NO | M | 7 | Secure Resources / People | X | X
01 | Trial Management | 01.03 | Data Adjudication | 01.03.01 | Independent Data Monitoring Committee Charter | Data Safety Monitoring Board (DSMB) Charter | To describe the purpose and mode of operation/manner of working of the Independent Data Monitoring Committee (IDMC), which may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data and the critical efficacy endpoints and to recommend to the sponsor whether to continue, modify or stop a trial. | Core (if applicable) | 5.5.2 | Data Monitoring Committee | 018 | X | NO-CS (if applicable) | X | NO-CS (if applicable) | D | 10 | Secure Resources / Committees | X
01 | Trial Management | 01.03 | Data Adjudication | 01.03.02 | Independent Data Monitoring Committee Member List | Data Safety Monitoring Board Member [NAME] | To document the current composition of the IDMC. | Core (if applicable) | 5.5.2 | Data Monitoring Committee | 019 | X | NO-CS (if applicable) | X | NO-CS (if applicable) | D | 10 | Secure Resources / Committees | X
01 | Trial Management | 01.03 | Data Adjudication | 01.03.03 | Independent Data Monitoring Committee Correspondence | Data Safety Monitoring Board Correspondence IDMC Data Package | To document any agreements or significant decisions regarding trial conduct, protocol violations, adverse event reporting, to include minutes, reports, notifications, recommendations from the IDMC. Applicable to interim and final analyses. | Core (if applicable) | 1.25 5.5.2 | Data Monitoring Committee | 020 | X | NO | X | NO | D | 31 | Manage Subject Risk / Resolve Trial Issues | X
01 | Trial Management | 01.03 | Data Adjudication | 01.03.04 | Adjudication Committee Document | End Point Committee Document | To describe in advance the decision-making process of the Committee that will evaluate key trial events (e.g. endpoints). | Core (if applicable) | 5.5.2 |  | 021 | X | NO-CS (if applicable) | X | NO-CS (if applicable) | D | 10 | Secure Resources / Committees | X
01 | Trial Management | 01.03 | Data Adjudication | 01.03.05 | Other Trial Committee Document |  | To document any agreements or significant discussions regarding trial administration, protocol violations, trial conduct, adverse event reporting from committees other than IDMC. To include charter, member list and correspondence. | Core (if applicable) |  |  | 022 | X | NO | X | NO | D | 31 | Manage Subject Risk / Resolve Trial Issues | X | X
01 | Trial Management | 01.03 | Data Adjudication | 01.03.06 | Dose Escalation |  | To document all correspondence and decisions regarding dose escalation, including approvals to move to the next dosing level. Often a committee | Core (if applicable) |  |  | 023 | X | NO | X | NO | M | 31 | Manage Subject Risk / Resolve Trial Issues | X
01 | Trial Management | 01.03 | Data Adjudication | 01.03.07 | Device Review Committee |  | Committee which may be established by the sponsor to assess at intervals the functioning of device or review of specified features in relationship to study objectives or safety and efficacy of device. | Core (if applicable) |  |  | 238 | NO | NO | X | NO | R | 10 | Secure Resources / Committees | X
01 | Trial Management | 01.04 | Meetings | 01.04.01 | Kick-off Meeting Material | Boot-up Meeting Material | Agenda, presentation materials and other documentation made available for attendees of the trial kick-off meeting, including attendance sheets. | Core |  |  | 024 | X | NO | X | NO | D | 21 | Manage Project / Report on Progress | X | X
01 | Trial Management | 01.04 | Meetings | 01.04.02 | Trial Team Training Material | Project Team Training Material | Trial-relevant training, including use of specialized systems, to provide evidence that trial team have appropriate qualifications and experience to conduct the trial, includes evidence of training (attendance sheets) and includes all training material. | Core | 5.4.1 |  | 025 | X | NO | X | NO | M | 26 | Manage Project / Manage People | X | X
01 | Trial Management | 01.04 | Meetings | 01.04.03 | Investigators Meeting Material |  | Agenda, presentation materials and other documentation made available for attendees of the investigator meeting(s). Includes meeting minutes or questions and answers (Q&A), attendance sheets and any pre-meeting material. | Core (if applicable) | 4.1.2 4.2.4 |  | 026 | X | XG  (if applicable) | X | XG  (if applicable) | D | 21 | Manage Project / Report on Progress | X | X
01 | Trial Management | 01.05 | General | 01.05.01 | Relevant Communications | Correspondence | Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes. Correspondence refering to general topics and/or topics across multiple zones may be filed with this zone | Core | 8.3.11 |  | 027 | X | NO | X | NO | M | 21 / Per content | Manage Project / Report on Progress / Per content | X | X
01 | Trial Management | 01.05 | General | 01.05.02 | Tracking Information |  | Zone-specific documents developed for the purpose of tracking activities during the course of the trial. | Recommended |  |  | 028 | X | NO | X | NO | R | Per content |  | X | X | X
01 | Trial Management | 01.05 | General | 01.05.03 | Other Meeting Material |  | Agenda, presentation materials and other documentation generated during any other internal or external zone-related meeting which documents any agreements or significant discussions.  Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material. | Core (if applicable) |  |  | 029 | X | NO | X | NO | D | Per content |  | X | X
01 | Trial Management | 01.05 | General | 01.05.04 | Filenote | Note to File | To document any decision or to clarify any information relating to this zone. Filenotes referencing general topics and/or topics across multiple zones may be files within this zone. | Core (if applicable) |  |  | 030 | X | NO | X | NO | D | Per content |  | X | X | X
02 | Central Trial Documents | 02.01 | Trial Documents | 02.01.01 | Investigator Brochure | IB | To provide relevant and current clinical and non-clinical data on the investigational product(s) that is related to the study of the product(s) in human subjects. | Core (if applicable) | 7.1 8.2.1 8.3.1 |  | 031 | X | XG | X | XG | M | 2 | Develop Study Design / Study Conduct | X
02 | Central Trial Documents | 02.01 | Trial Documents | 02.01.02 | Protocol | Clinical Investigation Plan (Devices) | To describe the objective(s), design, methodology, statistical considerations, and organization of a trial.  Usually also gives the background and rationale for the trial, but these could also be provided in other protocol referenced documents. Includes Special Protocols. | Core | 1.4.4 8.2.2 | Full Protocol | 032 | X | XG | X | XG | M | 2 | Develop Study Design / Study Conduct | X
02 | Central Trial Documents | 02.01 | Trial Documents | 02.01.03 | Protocol Synopsis | Protocol Summary Protocol Profile | A summary of the pertinent points of the protocol.  A local language version may be translated from core (English) or produced in the country if required by local Regulatory Authorities or IRB/IEC | Core (if applicable) |  | Synopsis | 033 | X | NO-CS (if applicable) | X | NO-CS (if applicable) | M | 4 | Develop Study Design / Document Development | X | X
02 | Central Trial Documents | 02.01 | Trial Documents | 02.01.04 | Protocol Amendment | Summary of Changes | To describe description of change(s) to or formal clarification of a protocol.  Includes justification for a non-substantial amendment, such as administrative changes. Includes Special Protocol Amendments. | Core (if applicable) | 1.4.5 8.3.2 | Protocol Amendment | 034 | X | XG or [NAME]  (if applicable) | X | XG or [NAME]  (if applicable) | M | 4 | Develop Study Design / Document Development | X | X | X
02 | Central Trial Documents | 02.01 | Trial Documents | 02.01.05 | Financial Disclosure Summary |  | Summary documentation of compliance with financial disclosure reporting requirements.  May include summaries, lists, other reports. | Recommended |  |  | 035 | X | NO | X | NO | D | 7 | Secure Resources / People | X | X
02 | Central Trial Documents | 02.01 | Trial Documents | 02.01.06 | Insurance |  | To document that compensation to subject(s) for trial-related injury will be available may include policy and certificates, terms and conditions. Certificate is core, policy is recommended | Core (if applicable) | 8.2.5 |  | 036 | X | XG  (if applicable) | X | XG  (if applicable) | M | 16 | Set up site(s) | X | X
02 | Central Trial Documents | 02.01 | Trial Documents | 02.01.07 | Sample Case Report Form | CRF/eCRF | Blank forms / templates in paper form or e-Format to capture the data points of the protocol. | Core | 8.2.2 8.3.2 | Sample CRF/eCRF | 037 | X | XG | X | XG | M | 4 | Develop Study Design / Document Development | X
02 | Central Trial Documents | 02.01 | Trial Documents | 02.01.10 | Report of Prior Investigations |  | To include reports of all prior clinical, animal, and laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation. Can be in addition or instead of an Investigator Brochure for device trials | Core (if applicable) | 21 CFR 812.27 |  | 239 | NO | NO | X | XG | M | 2 | Develop Study Design / Study Conduct | X
02 | Central Trial Documents | 02.02 | Subject Documents | 02.02.01 | Subject Diary |  | To document subject data captured away from the site (blank forms / templates). | Core (if applicable) |  |  | 038 | X | XG  (if applicable) | X | XG  (if applicable) | D | 4 | Develop Study Design / Document Development | X | X
02 | Central Trial Documents | 02.02 | Subject Documents | 02.02.02 | [NAME] |  | To capture specific subject related information through a series of questions (blank forms / templates) | Core (if applicable) |  |  | 039 | X | XG  (if applicable) | X | XG  (if applicable) | D | 3 | Develop Study Design / Capture Subject Data | X | X
02 | Central Trial Documents | 02.02 | Subject Documents | 02.02.03 | Informed Consent Form |  | To document that subjects have been given appropriate written information (content and wording) to support their ability to give fully informed consent and to document their consent in trial participation in writing. If applicable, must also include the child assent form (blank model / template). Please note that core template is Trial level, the country template is country level, and the site template is at the site level | Core | 8.2.3 8.3.2 | Informed Consent | 040 | X | XG or [NAME] | X | XG or [NAME] | M | 17 | Recruit Subjects & Obtain Consent | X | X | X
02 | Central Trial Documents | 02.02 | Subject Documents | 02.02.04 | Subject Information Sheet |  | The appropriate written information (content and wording) provided to the subject regarding the trial. | Core | 8.2.3 8.3.2 |  | 041 | X | XG or [NAME] | X | XG or [NAME] | D | 4 | Develop Study Design / Document Development | X | X | X
02 | Central Trial Documents | 02.02 | Subject Documents | 02.02.05 | Subject Participation Card |  | To be provided to the subject to carry to document trial participation (blank template). | Core (if applicable) | 8.2.3 8.3.2 |  | 042 | X | XG  (if applicable) | X | XG  (if applicable) | D | 4 | Develop Study Design / Document Development | X | X
02 | Central Trial Documents | 02.02 | Subject Documents | 02.02.06 | Advertisements for Subject Recruitment |  | To document recruitment materials used to locate subjects for participation in a clinical trial; approved by the IRB/IEC to ensure recruitment measures are appropriate and not coercive. | Core (if applicable) | 8.2.3 8.3.2 |  | 043 | X | XG or [NAME]  (if applicable) | X | XG or [NAME]  (if applicable) | D | 4 | Develop Study Design / Document Development | X | X | X
02 | Central Trial Documents | 02.02 | Subject Documents | 02.02.07 | Other Written Information Given to Subjects |  | To be provided to the subject to further assist with understanding the trial requirements or concepts; may include memory aids. | Core (if applicable) | 8.2.3 8.3.2 |  | 044 | X | XG  (if applicable) | X | XG  (if applicable) | D | 17 | Recruit Subjects & Obtain Consent | X | X | X
02 | Central Trial Documents | 02.03 | Reports | 02.03.01 | Clinical Study Report | Integrated Clinical & Statistical Report Abbreviated Clinical Study Report CSR FDA3654 (devices) | To describe final or interim results and interpretation of trial of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report; contains data listings and summaries. | Core | 1.13 8.4.8 | Legacy CSR Report Body | 045 | X | XG | X | XG | M | 40 | Report Data / Write Reports | X
02 | Central Trial Documents | 02.03 | Reports | 02.03.02 | Clinical Study Report Synopsis |  | A short summary of the study results taken from the full Clinical Study Report, primarily prepared for submission to regulatory bodies and/or IEC/IRBs. | Core (if applicable) |  |  | 046 | X | XG  (if applicable) | X | XG  (if applicable) | M | 38 | Report Data / Notify Bodies | X
02 | Central Trial Documents | 02.03 | Reports | 02.03.03 | Pharmacokinetics Report | PK Report | To present & summarize the relevant top line findings of the pharmacokinetic (PK) aspects of the interim or final analysis and may include PK analysis or reports. | Recommended |  |  | 047 | X | NO | NO | NO | R | 37 | Analyse Data / Final Data Analysis | X
02 | Central Trial Documents | 02.04 | General | 02.04.01 | Relevant Communications | Correspondence | Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes. | Core | 8.3.11 |  | 048 | X | NO | X | NO | D | Per content |  | X | X | X
02 | Central Trial Documents | 02.04 | General | 02.04.02 | Tracking Information |  | Zone-specific documents developed for the purpose of tracking activities during the course of the trial.  Includes Investigator Brochure Log | Recommended |  |  | 049 | X | NO | X | NO | R | Per content |  | X | X
02 | Central Trial Documents | 02.04 | General | 02.04.03 | Meeting Material |  | Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting which documents any agreements or significant discussions.  Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material. | Core (if applicable) |  |  | 050 | X | NO | X | NO | D | 21 | Manage Project / Report on Progress | X | X
02 | Central Trial Documents | 02.04 | General | 02.04.04 | Filenote | Note to File | To document any decision or to clarify any information relating to this zone. | Core (if applicable) |  |  | 051 | X | NO | X | NO | D | Per content |  | X | X | X
03 | Regulatory | 03.01 | Trial Approval | 03.01.01 | Submission |  | A set of documents, along with required regulatory forms, submitted to one or more regulatory agencies requesting approval to conduct the trial or for the purpose of notification, or requesting approval of changes to the trial documents or of any trial events that could adversely affect the safety of subjects, impact the conduct of the trial or alter the regulatory authority's approval/favorable opinion to continue the trial. Example Investigational New Drug Application (IND), Clinical Trial Application (CTA), Investigational Medicinal Product Dossier (IMPD), Investigational Device Exemption (IDE) | Recommended |  |  | 052 | X | NO-CS | X | NO-CS | R | 13 | Secure Ethical Approvals |  | X
03 | Regulatory | 03.01 | Trial Approval | 03.01.02 | Approval |  | A document received from a regulatory authority stating that the Submission has been received and approved. Includes conditional approval notifications | Core (if applicable) | 8.2.9 8.3.4 | Letter of Authorization | 053 | X | XG  (if applicable) | X | XG  (if applicable) | M | 14 | Secure Regulatory Approval |  | X
03 | Regulatory | 03.01 | Trial Approval | 03.01.03 | Notification of Regulatory Identification Number |  | Document identifying unique Identification (ID) number used to uniquely identify the trial or the trial level in that region, assigned by a regulatory agency – e.g. EU = EudraCT Number, FDA = IND Number, US Device = IDE Number. | Core |  |  | 054 | X | NO | X | NO | D | 14 | Secure Regulatory Approval |  | X
03 | Regulatory | 03.01 | Trial Approval | 03.01.04 | Public Registration |  | Documentation related to registration of clinical trials in public registries such as ClinicalTrials.gov and to submission of results periodically during the study and at study completion. | Core (if applicable) |  |  | 055 | X | NO | X | NO | D | 11 | Notify Regulatory Agency of Trial | X | X
03 | Regulatory | 03.02 | Investigational Medicinal Product | 03.02.01 | Import/Export License Application |  | An application made to one or more regulatory agencies requesting a license to import or export the investigational product and clinical supplies. | Core (if applicable) |  |  | 056 | X | NO | X | NO | D | 13 | Secure Ethical Approvals |  | X
03 | Regulatory | 03.02 | Investigational Medicinal Product | 03.02.02 | Import/Export License |  | A document issued by a national government authorizing the importation or exportation of certain goods into its territory. | Core (if applicable) |  |  | 057 | X | XG  (if applicable) | X | XG  (if applicable) | D | 6 | Secure Resources / Supplies |  | X
03 | Regulatory | 03.03 | Trial Status Reporting | 03.03.01 | Notification to Regulatory Authority of Safety/Trial Information | Safety Report. | Notification to Regulatory Authorities of any trial events that could adversely affect the safety of subjects, impact the conduct of the trial or alter the regulatory authority's approval/favorable opinion to continue the trial. Notifications may include but are not limited to Quarterly line listings, suspected unexpected serious adverse reactions (SUSARs), Unexpected Serious Adverse Device Events (USADE), Council for International Organizations of Medical Sciences (CIOMS), xEVMPD, MedWatch, Analysis of Similar Events, [NAME], cover letters and/or country-specific reporting forms. | Core | 8.3.17 |  | 058 | X | NO-CS | X | NO-CS | M | 28 | Manage Subject Risk / Report Safety Issue(s) |  | X
03 | Regulatory | 03.03 | Trial Status Reporting | 03.03.02 | Progress Report |  | Reports concerning trial conduct, other than safety reports filed with Regulatory Authorities across the conduct of a trial; i.e., Periodic Report, Interim Report, Annual Report. | Core |  |  | 059 | X | NO-CS | X | NO-CS | M | 39 | Report Data / Provide Trial Updates |  | X
03 | Regulatory | 03.03 | Trial Status Reporting | 03.03.03 | Notification of Trial Termination |  | Document detailing the termination of a trial – whether upon completion or premature termination. | Core (if applicable) | 4.12, 5.21 | Notification of Discontinuation of Clinical Trial | 060 | X | NO | X | NO | M | 32 | Close Site(s) / Notify Bodies |  | X
03 | Regulatory | 03.04 | General | 03.04.01 | Relevant Communications | Correspondence | Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes. | Core | 8.3.11 |  | 061 | X | NO | X | NO | D | Per content |  | X | X
03 | Regulatory | 03.04 | General | 03.04.02 | Tracking Information |  | Zone-specific documents developed for the purpose of tracking activities during the course of the trial. | Recommended |  |  | 062 | X | NO | X | NO | D | Per content |  | X | X | X
03 | Regulatory | 03.04 | General | 03.04.03 | Meeting Material |  | Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting which documents any agreements or significant discussions.  Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material. | Core (if applicable) |  |  | 063 | X | NO | X | NO | D | 14 | Secure Regulatory Approval | X | X
03 | Regulatory | 03.04 | General | 03.04.04 | Filenote | Note to File | To document any decision or to clarify any information relating to this zone. | Core (if applicable) |  |  | 064 | X | NO | X | NO | D | 13 | Secure Ethical Approvals | X | X
04 | IRB/IEC and other Approvals | 04.01 | IRB/IEC Trial Approval | 04.01.01 | IRB/IEC Submission |  | A set of documents describing the trial or changes/updates to the trial submitted to an IRB/IEC for approval, including recruitment and education materials. | Core | 8.2.7 8.3.3 |  | 065 | X | XG or [NAME] | X | XG or [NAME] | M | 13 | Secure Ethical Approvals |  | X | X
04 | IRB/IEC and other Approvals | 04.01 | IRB/IEC Trial Approval | 04.01.02 | IRB/IEC Approval | IRB/IEC Continuing Review of Trial | Documentation received from IRB/IEC sometimes in response to submission indicating approval/acknowledgement of trial and any specifications or modifications.  Includes waiver of IRB requirements, conditional approvals and continuing review of trial | Core | 8.2.7 8.3.3 |  | 066 | X | XG or [NAME] | X | XG or [NAME] | M | 13 | Secure Ethical Approvals |  | X | X
04 | IRB/IEC and other Approvals | 04.01 | IRB/IEC Trial Approval | 04.01.03 | IRB/IEC Composition | Reviewer Participant List Membership List | Documentation that the IRB/IEC consists of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. | Core | 8.2.8 |  | 067 | X | XG or [NAME] | X | XG or [NAME] | M | 13 | Secure Ethical Approvals |  | X | X
04 | IRB/IEC and other Approvals | 04.01 | IRB/IEC Trial Approval | 04.01.04 | IRB/IEC Documentation of Non-Voting Status |  | Documentation verifying non-voting members of the IRB/IEC if the investigator or sub-investigator is on the IRB/IEC. | Core (if applicable) | 3.2.1 |  | 068 | X | XG or [NAME]  (if applicable) | X | XG or [NAME]  (if applicable) | M | 13 | Secure Ethical Approvals |  | X | X
04 | IRB/IEC and other Approvals | 04.01 | IRB/IEC Trial Approval | 04.01.05 | IRB/IEC GCP Compliance Statement | Attestation Form | Documentation that the IRB/IEC is performing its function according to written operating procedures and is in compliance with GCP and applicable regulatory requirements. | Core (If applicable) | 3.2.2 3.4 |  | 069 | X | XG or [NAME]  (if applicable) | X | XG or [NAME]  (if applicable) | M | 15 | Secure Other Approvals |  | X | X
04 | IRB/IEC and other Approvals | 04.02 | Other Committees | 04.02.01 | Other Submissions |  | A set of documents describing the trial or changes/updates to the trial submitted to a committee other than the IRB/IEC for approval. Examples include Scientific, Institutional, Financial, Data Protection, Biobank. To include: Submissions and Correspondence | Recommended |  |  | 070 | X | XG or [NAME] | X | XG or [NAME] | R | 15 | Secure Other Approvals | X | X | X
04 | IRB/IEC and other Approvals | 04.02 | Other Committees | 04.02.02 | Other Approvals |  | Documentation received from the Approval Committee in response to submission indicating approval/acknowledgement of trial specifications or modifications. Examples include Scientific, Institutional, Financial, Data Protection, Biobank. To include: Submissions and Correspondence | Core (if applicable) |  |  | 071 | X | XG or [NAME]  (if applicable) | X | XG or [NAME]  (if applicable) | D | 15 | Secure Other Approvals | X | X | X
04 | IRB/IEC and other Approvals | 04.03 | Trial Status Reporting | 04.03.01 | Notification to IRB/IEC of Safety Information |  | To assure the IRB/IEC are promptly notified of all findings (new, important information on serious adverse events and or safety concerns) that could adversely affect the safety of subjects, impact the conduct of the trial or alter the IRB/IEC's  approval/favorable opinion to continue the trial.   [NAME] may include but are not limited to Quarterly line listings, USADEs, SUSARs, CIOMS, MedWatch, Analysis of Similar Events, cover letters and/or IRB/IEC-specific reporting forms. | Core | 8.3.17 4.3.1 4.4.3 4.10.2 |  | 072 | X | XG or [NAME] | X | XG or [NAME] | M | 28 | Manage Subject Risk / Report Safety Issue(s) |  | X | X
04 | IRB/IEC and other Approvals | 04.03 | Trial Status Reporting | 04.03.02 | IRB/IEC Progress Report |  | Regular reports concerning trial conduct, other than safety reports, issued to the IRB/IEC by the sponsor/3rd Party and/or investigator e.g. [NAME] or Annual Reports. | Core | 8.3.19 3.1.4 4.4.3 4.10.1 4.10.2 |  | 073 | X | XG or [NAME] | X | XG or [NAME] | M | 39 | Report Data / Provide Trial Updates |  | X | X
04 | IRB/IEC and other Approvals | 04.03 | Trial Status Reporting | 04.03.03 | IRB/IEC Notification of Trial Termination |  | Document detailing the termination of a trial – whether upon completion or premature termination. | Core | 4.13 4.12 5.21 |  | 074 | X | XG or [NAME] | X | XG or [NAME] | M | 32 | Close Site(s) / Notify Bodies |  | X | X
04 | IRB/IEC and other Approvals | 04.04 | General | 04.04.01 | Relevant Communications | Correspondence | Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes. | Core | 8.3.11 |  | 075 | X | XG or [NAME] | X | XG or [NAME] | M | Per content |  | X | X | X
04 | IRB/IEC and other Approvals | 04.04 | General | 04.04.02 | Tracking Information |  | Zone-specific documents developed for the purpose of tracking activities during the course of the trial. | Recommended |  |  | 076 | X | NO | X | NO | R | 21 | Manage Project / Report on Progress | X | X | X
04 | IRB/IEC and other Approvals | 04.04 | General | 04.04.03 | Meeting Material |  | Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting which documents any agreements or significant discussions.  Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material. | Core (if applicable) |  |  | 077 | X | NO | X | NO | D | 13 | Secure Ethical Approvals | X | X | X
04 | IRB/IEC and other Approvals | 04.04 | General | 04.04.04 | Filenote | Note to File | To document any decision or to clarify any information relating to this zone. | Core (if applicable) |  |  | 078 | X | NO | X | NO | D | Per content |  | X | X | X
05 | Site Management | 05.01 | Site Selection | 05.01.01 | Site Contact Details |  | To document contact information for primary points of contact at the site (e.g. Principal Investigator, Institution Name, Trial Coordinator, Contracts, etc). | Recommended |  |  | 079 | X | XS | X | XS | R | 7 | Secure Resources / People |  |  | X
05 | Site Management | 05.01 | Site Selection | 05.01.02 | Confidentiality Agreement | Secrecy Agreement | A document between the sponsor and an outside party (Investigator or Institution) that defines the terms and basic criteria to assure that the party (or parties) receiving confidential information will maintain confidentiality and will not use that information for any purpose other than that described in the Agreement. May also be present in the Clinical Trial Agreement | Core | 1.16 |  | 080 | X | XS | X | XS | D | 7 | Secure Resources / People |  |  | X
05 | Site Management | 05.01 | Site Selection | 05.01.03 | Feasibility Documentation | Site Selection Documentation | To document site feasibility for the given protocol. | Recommended |  |  | 081 | X | NO | X | NO | D | 5 | Develop Study Design / Feasibility & Site Evaluation | X | X | X
05 | Site Management | 05.01 | Site Selection | 05.01.04 | Pre Trial Monitoring Report | Pre-Study Visit Report Site Evaluation Visit Report | To document onsite visit to determine qualification of site to participate in the trial. Includes EDC qualification | Core | 8.2.19 |  | 082 | X | NO | X | NO | D | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.01 | Site Selection | 05.01.05 | Sites Evaluated but not Selected | Investigators not used | Documentation related to sites evaluated but not selected for the trial. | Recommended |  |  | 083 | X | NO | X | NO | D | 7 | Secure Resources / People | X | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.01 | Acceptance of Investigator Brochure | IB Receipt Confirmation IB Acknowledgement of Receipt Acknowledgement of receipt of report of prior investigations | To document that IB was sent and received. | Recommended |  |  | 084 | X | XS | X | XS | R | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.02 | Protocol Signature Page |  | To document investigator and sponsor agreement to the protocol. | Core | 8.2.2 | Signature Page | 085 | X | XS | X | XS | M | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.03 | Protocol Amendment Signature Page | Clinical Investigation Plan Signature Page | To document investigator and sponsor agreement to the protocol amendment. | Core (if applicable) | 8.2.2 | Signature Page | 086 | X | XS  (if applicable) | X | XS  (if applicable) | M | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.04 | Principal Investigator [NAME] |  | To document qualifications and eligibility of the Principal Investigator to conduct trial and/or provide medical supervision of subjects. To include updates. | Core | 8.2.10 8.3.5 | Investigator CVs | 087 | X | XS | X | XS | M | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.05 | Sub-Investigator [NAME] |  | To document qualifications and eligibility of any sub-Investigators to conduct trial and/or provide medical supervision of subjects. Sub-Investigators include any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). To include updates. | Core (if applicable) | 8.2.10 8.3.5 |  | 088 | X | XS  (if applicable) | X | XS  (if applicable) | D | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.06 | Other Curriculum Vitae |  | To document qualifications and eligibility of site personnel other than the Principal Investigator or Sub-Investigators to conduct trial and/or provide medical supervision of subjects. | Core (if applicable) | 8.2.10 |  | 089 | X | XS  (if applicable) | X | XS  (if applicable) | D | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.07 | Site and Staff Qualification Supporting Information |  | To document site / site staff qualifications not previously outlined on CVs.  May include list of previous studies, publications, training certificates for specific examinations, ICH-GCP training, site GCP or trial licensure, medical licenses etc. | Recommended |  |  | 090 | X | XS | X | XS | R | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.08 | Form FDA1572 |  | For IND trial, 1572 must be completed globally for FDA submission. | Core (if applicable) | 8.2.6 |  | 091 | X | XS  (if applicable) | NO | NO | M (US) | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.09 | Investigator [NAME] |  | A regulatory statement from the investigator required by certain health authorities e.g. includes but is not limited to ‘Qualified Investigator Undertaking’ form and ‘Clinical Trial Site Information’ form required by Health Canada | Core (if applicable) | 8.2.6 |  | 092 | X | XS  (if applicable) | X | XS  (if applicable) | M (non-US) | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.10 | Financial Disclosure Form |  | To certify that no financial arrangements with an investigator have been made where study outcome could affect compensation; that the investigator has no proprietary interest in the tested product; that the investigator does not have a significant equity interest in the sponsor of the covered study; and that the investigator has not received significant payments of other sorts; and/or disclosure of specified financial arrangements and any steps taken to minimize the potential for bias. | Core (if applicable) | 8.2.4 | Financial Disclosure Information | 093 | X | XS  (if applicable) | X | XS  (if applicable) | M (US) | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.11 | Data Privacy Agreement | Personal Data Consent | To document agreement between Sponsor and Site Staff (EU); often contained in Clinical Trial Agreement | Recommended |  |  | 094 | X | XS | X | XS | R | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.12 | Clinical Trial Agreement | Clinical Study Agreement, Investigator Financial Agreement Investigator Contract | To document agreement of trial requirements between sponsor or 3rd Party and site/ PI. Includes indemnity unless separate document created. | Core | 8.2.4 8.2.6 |  | 095 | X | XS | X | XS | D | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.13 | Indemnity |  | To provide legal protection in the event of an unforeseen adverse circumstance arising during the course of a clinical trial. May be in Clinical Trial Agreement | Core (if applicable) | 8.2.4 8.2.6 |  | 096 | X | XS  (if applicable) | X | XS  (if applicable) | D | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.14 | Other Financial Agreement |  | To document agreement of trial requirements between other parties involved in the conduct of the trial. Includes indemnity unless separate document created. e.g. Pharmacy agreement, other department agreement, institutional agreement. | Core (if applicable) | 8.2.4 8.2.6 |  | 097 | X | XS  (if applicable) | X | XS  (if applicable) | D | 6 | Secure Resources / Supplies |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.15 | Local Laboratory Certification or Accreditation | Qualifications Confirmation for inter-laboratory standardization program | To document recognition and approval by an authorized accrediting body applying known acceptable standards, that the facility is competent to perform required test(s), and support reliability of results. May include Lab Director [NAME] | Core (if applicable) | 8.2.12 8.3.7 |  | 098 | X | XS  (if applicable) | X | XS  (if applicable) | D | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.16 | Local Laboratory Normal Ranges | [NAME] | To define acceptable limits (where 95% of the population that a laboratory serves will fall) for comparative interpretation that allow for medical decisions to be made;  may be included in User Manual. | Core (if applicable) | 8.2.11 8.3.6 |  | 099 | X | XS  (if applicable) | X | XS  (if applicable) | D | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.17 | IP Site Release Documentation | Drug Release Document Authorization to Ship Clinical Trial Materials | To document approval for sites to receive drug supply / investigational product. | Recommended | 5.14.2 |  | 100 | X | NO | X | NO | D | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.18 | Site Signature Sheet | Delegation of Authority Site Responsibility Log | To document delegation by the Principal Investigator of trial specific tasks to site personnel conducting the trial. | Core | 4.1.5 8.3.24 |  | 101 | X | XS | X | XS | M | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.02 | Site Set-up Documentation | 05.02.19 | Investigators Agreement (Device) |  | Non-financial agreement between the sponsor and the investigator documenting the various responsibilities, as outlined in CFR Title 21 part 812 as well as ICH-E6 (if applicable), in which the investigator will comply. | Core | 812.43c |  | 240 | NO | NO | X | XS  (if applicable) | D | 16 | Set up site(s) |  |  | X
05 | Site Management | 05.03 | Site Initiation | 05.03.01 | Trial Initiation Monitoring Report | Site Initiation Visit Report | To document visit to initiate site and confirm requirements have been met to begin trial participation, and that trial procedures were reviewed with the investigator and trial personnel at the site. | Core | 8.2.20 |  | 102 | X | XS | X | XS | D | 19 | Monitor Site(s) |  |  | X
05 | Site Management | 05.03 | Site Initiation | 05.03.02 | Site Training Material |  | To demonstrate material used to train sites.  Includes electronic data capture (EDC) training | Core (if applicable) | 4.1.1 |  | 103 | X | XG  (if applicable) | X | XG  (if applicable) | D | 16 | Set up site(s) | X | X | X
05 | Site Management | 05.03 | Site Initiation | 05.03.03 | Site Training Documentation | Training completion documentation | To document completion of site training, including attendance and certification. Includes EDC training | Core (if applicable) | 4.1.1 |  | 104 | X | XS  (if applicable) | X | XS  (if applicable) | M | 16 | Set up site(s) | X | X | X
05 | Site Management | 05.04 | Site Management | 05.04.01 | Subject Log |  | To anonymously list all subjects including screened, screen failures and enrolled  for the Sponsor. Not anonymous at the Investigator site | Core | 8.3.20 8.3.22 |  | 105 | X | XS | X | XS | M | 17 | Recruit Subjects & Obtain Consent |  |  | X
05 | Site Management | 05.04 | Site Management | 05.04.02 | Source Data Verification |  | To document source data and  associated verification activity | Recommended |  |  | 106 | X | NO | X | NO | D | 20 | Manage Project | X |  | X
05 | Site Management | 05.04 | Site Management | 05.04.03 | Monitoring Visit Report |  | To document site visits monitoring trial conduct and compliance of the site, may include follow-up letter. | Core | 8.3.10 |  | 107 | X | NO | X | NO | D | 19 | Monitor Site(s) |  |  | X
05 | Site Management | 05.04 | Site Management | 05.04.04 | Visit Log |  | To document monitoring visit dates and attendees. | Core |  |  | 108 | X | XS | X | XS | D | 19 | Monitor Site(s) |  |  | X
05 | Site Management | 05.04 | Site Management | 05.04.05 | Additional Monitoring Activity |  | To document additional monitoring activity such as co-visits and Sponsor-specific monitoring activities | Core (if applicable) |  |  | 109 | X | NO | X | NO | D | 19 | Monitor Site(s) |  |  | X
05 | Site Management | 05.04 | Site Management | 05.04.06 | Protocol Deviations | Protocol Deviation Report Deviation Log | To document non-compliance/ deviations to the protocol. | Core (if applicable) | 3.3.8 5.18.4 |  | 110 | X | XS  (if applicable) | X | XS  (if applicable) | M | 19 | Monitor Site(s) | X |  | X
05 | Site Management | 05.04 | Site Management | 05.04.07 | Financial Documentation |  | Includes all invoices, receipts, payment summaries relating to the trial | Recommended |  |  | 111 | X | XS | X | XS | R | 24 | Manage Project / Manage Budget |  |  | X
05 | Site Management | 05.04 | Site Management | 05.04.08 | Final Trial Close Out Monitoring Report | Trial Termination Visit Report Close Out Visit report | To document trial activities are completed for site closure prior to trial completion. | Core | 8.4.5 |  | 112 | X | NO | X | NO | D | 34 | Close Site(s) / Close Site |  |  | X
05 | Site Management | 05.04 | Site Management | 05.04.09 | Notification to Investigators of Safety Information | Dear Doctor Dear Health Care Provider Letter Safety Letter SUSAR Notification USADE Notification | To assure investigators are promptly notified of all findings (new, important information on serious adverse events and or safety concerns) that could adversely affect the safety of subjects, impact the conduct of the trial or alter their IRB/IEC's approval/favorable opinion to continue the trial.   [NAME] may include but are not limited to Quarterly line listings, SUSARs, CIOMS, MedWatch, Analysis of Similar Events, cover letters and/or country-specific reporting forms. | Core (if applicable) | 5.16.2 5.17 8.3.17-18 |  | 113 | X | XS  (if applicable) | X | XS  (if applicable) | D | 28 | Manage Subject Risk / Report Safety Issue(s) | X |  | X
05 | Site Management | 05.04 | Site Management | 05.04.10 | Subject Identification Log |  | To fully identify all subjects screened, screen failed and enrolled in the trila, with unique institution identifiers where relevant | Core | 8.3.20 8.3.23 |  | 234 | NO | XS | NO | XS | M | 17 | Recruit Subjects & Obtain Consent |  |  | X
05 | Site Management | 05.04 | Site Management | 05.04.11 | Source Data |  | To document source data information at the Investigator site | Core | 8.3.13 |  | 235 | NO | XS | NO | XS | M | 18 | Complete Subject Study Visit |  |  | X
05 | Site Management | 05.04 | Site Management | 05.04.12 | Monitoring Visit Follow-up Letter | Monitoring Visit Follow-up Communications | To document site visit follow-up. Could be grouped with monitoring visit reports. | Core | 8.3.11 |  | 241 | X | XS | X | XS | D | 19 | Monitor Site(s) |  |  | X
05 | Site Management | 05.05 | General | 05.05.01 | Relevant Communications | Correspondence | Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes. Should not include monitoring visit follow-up letter. | Core | 8.3.11 |  | 114 | X | XS | X | XS | D | Per content |  | X | X | X
05 | Site Management | 05.05 | General | 05.05.02 | Tracking Information |  | Zone-specific documents developed for the purpose of tracking activities during the course of the trial. | Recommended |  |  | 115 | X | XS | X | XS | R | Per content |  | X | X | X
05 | Site Management | 05.05 | General | 05.05.03 | Meeting Material |  | Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting which documents any agreements or significant discussions.  Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material. | Core (if applicable) |  |  | 116 | X | XS  (if applicable) | X | XS  (if applicable) | D | 25 | Manage Project / Oversee Vendor(s) | X | X | X
05 | Site Management | 05.05 | General | 05.05.04 | Filenote | Note to File | To document any decision or to clarify any information relating to this zone. | Core (if applicable) |  |  | 117 | X | XS  (if applicable) | X | XS  (if applicable) | D | 19 | Monitor Site(s) | X | X | X
06 | IP and Trial Supplies | 06.01 | IP Documentation | 06.01.01 | IP Supply Plan | Trial Medication Plan Clinical Trial Material Distribution Plan IP Supply & Packaging Plan | To document written procedures which define the following as they pertain to the IP: 1) quantity and packaging of active, placebo, and/or if applicable, comparator or rescue supplies needed to fulfill the requirements of the trial protocol over the life of the trial, and 2) acceptable storage temperatures and conditions, storage times, reconstitution fluids and procedures, and devices for product infusion. | Recommended | 2.13 5.13.3 |  | 118 | X | NO | X | NO | D | 22 | Manage Project / Manage IMP | X | X
06 | IP and Trial Supplies | 06.01 | IP Documentation | 06.01.02 | IP Instructions for Handling | Pharmacy Manual Device User Manual | To instruct on how the IP should be handled during transit and stored upon arrival at the distribution center, depot, and/or trial site.  The content should address expectations for adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from subjects, and return of unused IP to the sponsor (or their delegate) If appropriate to the trial, includes preparation of the IP leading to administration. | Core | 5.13.2 5.14.3 8.2.14 |  | 119 | X | XG | X | XG | D | 22 | Manage Project / Manage IMP | X | X
06 | IP and Trial Supplies | 06.01 | IP Documentation | 06.01.03 | IP Sample Label |  | A sample of each IP label type (for every pack and every language) to be used in the trial; approval status must be clear; translation certificates are to be included.  All stages of label text development are included within this artifact. | Core | 5.13.1 8.2.13 |  | 120 | X | NO-CS | X | NO-CS | D | 4 | Develop Study Design / Document Development | X | X
06 | IP and Trial Supplies | 06.01 | IP Documentation | 06.01.04 | IP Shipment Documentation |  | To detail inventories of shipment approval process, requests, dispatch, tracking, and receipts to/from a distribution center, depot, and/or trial site.  Examples include pro forma or commercial invoice, courier documentation, and packing/ inventory listing. | Core | 5.14.4 8.2.15 8.3.8 |  | 121 | X | XS | X | XS | D | 22 | Manage Project / Manage IMP | X | X | X
06 | IP and Trial Supplies | 06.01 | IP Documentation | 06.01.05 | Accountability Documentation | Inventory Documentation | To document records of the dispensing IP to/from a distribution center, depot, trial site and/or site to subject and the reconciliation of IP prior to return to the sponsor. | Core | 5.14.4 8.3.23 8.4.1 |  | 122 | X | XS | X | XS | M | 22 | Manage Project / Manage IMP | X | X | X
06 | IP and Trial Supplies | 06.01 | IP Documentation | 06.01.06 | IP Documentation of Transfer |  | To document the transfer of IP between depots and sites (within or across protocols).  Examples include sponsor approval for transfer  and evidence of consultation with [NAME] (QP). | Core (if applicable) | 5.14.4 |  | 123 | X | XS  (if applicable) | X | XS  (if applicable) | D | 22 | Manage Project / Manage IMP | X | X | X
06 | IP and Trial Supplies | 06.01 | IP Documentation | 06.01.07 | Re-labeling Documentation |  | To document the well described plan for the re-labeling process to occur at the depot and/or site and confirmation records that the re-labeling occurred. | Core (if applicable) | 5.14.4 |  | 124 | X | XS  (if applicable) | X | XS  (if applicable) | D | 22 | Manage Project / Manage IMP | X | X | X
06 | IP and Trial Supplies | 06.01 | IP Documentation | 06.01.08 | IP Recall Documentation |  | To document the well described plan for the recall process for the IP to occur at a distribution center, depot and/or site; will include confirmation records that the recall occurred. | Core (if applicable) | 5.14.4 |  | 125 | X | XS  (if applicable) | X | XS  (if applicable) | D | 22 | Manage Project / Manage IMP | X | X | X
06 | IP and Trial Supplies | 06.01 | IP Documentation | 06.01.09 | IP Quality Complaint Form | Device deficiency documentation | To document or record a product complaint. | Core (if applicable) | 5.14.4 |  | 126 | X | XS  (if applicable) | X | XS  (if applicable) | D | 22 | Manage Project / Manage IMP | X |  | X
06 | IP and Trial Supplies | 06.01 | IP Documentation | 06.01.10 | IP Documentation Return |  | To detail inventories of returns to/from a distribution center, depot, and/or trial site.   Examples include courier documentation and packing/ inventory listing. | Core | 5.14.4 8.2.15 8.3.9 |  | 127 | X | XS | X | XS | M (if applicable) | 33 | Close Site(s) / Reconcile Trial Materials | X | X | X
06 | IP and Trial Supplies | 06.01 | IP Documentation | 06.01.11 | Certificate of Destruction | Documentation of Destruction | To document the confirmation of destruction of IP at the end of a trial at a distribution center, depot, and/or site . | Core | 5.14.4 |  | 128 | X | XS | X | XS | M (if applicable) | 33 | Close Site(s) / Reconcile Trial Materials | X | X | X
06 | IP and Trial Supplies | 06.01 | IP Documentation | 06.01.12 | Retest and [NAME] |  | To document the batch retesting/analyses of IP for a variety of reasons such as stability confirmation and expiry extension | Core (if applicable) | 5.14.5 |  | 242 | X | XG  (if applicable) | X | XG  (if applicable) | M (if applicable) | 22 | Manage Project / Manage IMP/Device | X | X | X
06 | IP and Trial Supplies | 06.02 | IP Release Process Documentation | 06.02.01 | QP (Qualified Person) Certification |  | To confirm that any IP from another country has been manufactured and checked in accordance with standards of Good Manufacturing Practices (GMP) at least equivalent to those laid down in Directive 91/356/EEC.  Documents the technical release documentation including GMP certification and the name / address of the manufacturer.  First stage of a multi-stage release process, if release process required. | Core (if applicable) | 2.12 5.13.1 |  | 129 | X | XG  (if applicable) | X | XG  (if applicable) | M (if applicable) | 6 | Secure Resources / Supplies | X | X
06 | IP and Trial Supplies | 06.02 | IP Release Process Documentation | 06.02.02 | IP Regulatory Release Documentation |  | To document all regulatory IP release. Second stage of a multi-stage release process, if release process required. | Core | 2.12 5.14.5 |  | 130 | X | NO | X | NO | D | 22 | Manage Project / Manage IMP | X | X
06 | IP and Trial Supplies | 06.02 | IP Release Process Documentation | 06.02.03 | IP Verification Statements |  | Any certificate, license, or other documentation that is required by a specific regulation to verify the quality, source, manufacture, ingredients or other aspect of investigational and/or control product. Examples include TSE certificate, Controlled IP storage, and GMP [NAME]. | Core (if applicable) | 8.2.15 8.3.8 |  | 131 | X (if appl) | XG  (if applicable) | X | XG  (if applicable) | M (if applicable) | 22 | Manage Project / Manage IMP | X | X | X
06 | IP and Trial Supplies | 06.02 | IP Release Process Documentation | 06.02.04 | Certificate of Analysis |  | To document identity, purity, and strength of the IP(s) to be used trial, in accordance with the specifications of the IP, including the acceptance limits and the actual results of the tests. | Core | 2.12 5.13.5 8.2.16 8.3.9 |  | 132 | X | NO-CS | X | NO-CS | M (if applicable) | 22 | Manage Project / Manage IMP | X
06 | IP and Trial Supplies | 06.03 | IP Allocation Documentation | 06.03.01 | Treatment Allocation Documentation | Randomization envelopes Emergency decode envelopes (or lists), Blinded Codes | To documentthe treatment allocation, or device serial numbers, for each subject. Used if urgent unblinding or code break is needed, or when interim or final unblinding occurs. | Core | 5.13.4 |  | 133 | X | XS | X | XS | M (if applicable) | 22 | Manage Project / Manage IMP/Device | X |  | X
06 | IP and Trial Supplies | 06.03 | IP Allocation Documentation | 06.03.02 | Unblinding Plan | Decoding Procedure | To document the plan and procedures to be taken should the action of breaking the blind for an individual subject be urgently needed, or when interim or final unblinding occurs. | Core | 5.13.4 8.2.17 8.4.3 |  | 134 | X | XG  (if applicable) | X | XG  (if applicable) | M (if applicable) | 12 | Develop Trial Management Strategy | X |  | X
06 | IP and Trial Supplies | 06.03 | IP Allocation Documentation | 06.03.03 | Treatment Decoding Documentation | Code Break Unblinding | To document the action of breaking the blind for an individual subject,  urgently if needed, or when interim or final unblinding occurs. Treatment unblinding may be controlled by interactive response technology (IRT) and or manually using  code break envelopes. | Core | 5.13.4 8.4.6 |  | 135 | X | XS | X | XS  (if applicable) | M (if applicable) | 30 | Manage Subject Risk / Break Blind | X |  | X
06 | IP and Trial Supplies | 06.04 | Storage | 06.04.01 | Storage Condition Documentation |  | To document the unique storage conditions of the IP, Non IP and other trial supplies at the sponsor (if sponsor is distributing), distribution center, depot, trial site and in transit, if required by the available stability requirements of the IP. | Core (if applicable) | 5.14.4 |  | 136 | X | XS  (if applicable) | X | XS  (if applicable) | M (if applicable) | 22 | Manage Project / Manage IMP/Device | X | X | X
06 | IP and Trial Supplies | 06.04 | Storage | 06.04.02 | Storage Condition Excursion Documentation |  | To record excursions for IP, Non-IP and other trial supplies from the acceptable pre-defined condition range either during transit or storage at a distribution center, depot, and/or trial site. | Core (if applicable) | 5.14.4 |  | 137 | X | XS  (if applicable) | X | XS  (if applicable) | M (if applicable) | 22 | Manage Project / Manage IMP/Device | X | X | X
06 | IP and Trial Supplies | 06.04 | Storage | 06.04.03 | [NAME] (Device) |  | To record activities and times when quality of condition of IP assessed and stable over period of use and maintenance performed, including software logs. | Core (if applicable) | 5.14.5 |  | 243 | NO | NO | X | XS  (if applicable) | M (if applicable) | 22 | Manage Project / Manage IMP/Device | X |  | X
06 | IP and Trial Supplies | 06.05 | Non-IP Documentation | 06.05.01 | Non-IP Supply Plan |  | An agreed upon plan which defines the details and quantity of non-IP supplies needed to fulfill the trial protocol requirements over the life of the trial. This may include but is not limited to rescue medication, supplementary medication, pre-treatment, other prophylactic therapies, drug delivery supplies (IV tubing, syringes), thermometers, and respirometers. | Recommended |  |  | 138 | X | NO | X | NO | D | 12 | Develop Trial Management Strategy | X | X
06 | IP and Trial Supplies | 06.05 | Non-IP Documentation | 06.05.02 | Non-IP Documentation of Shipment |  | To inventory the shipment and any returns of certain non-IP supplies needed to fulfill the trial protocol requirements to a distribution center, depot, and/or site. | Recommended |  |  | 139 | X | XS | X | XS | D | 23 | Manage Project / Manage Non-IMP | X |  | X
06 | IP and Trial Supplies | 06.05 | Non-IP Documentation | 06.05.03 | Non-IP Documentation of Return |  | To inventory the returns of certain non-IP supplies needed to fulfill the trial protocol requirements to a distribution center, depot, and/or site.  Examples include courier documentation and packing/ inventory listing. | Recommended |  |  | 140 | X | XS | X | XS | D | 23 | Manage Project / Manage Non-IMP | X |  | X
06 | IP and Trial Supplies | 06.06 | Interactive Response Technology | 06.06.01 | IRT User Requirement Specification |  | To document end user requirements from design and capabilities of the interactive response technology (IRT) such as Interactive Voice Randomization System (IVRS) or Interactive Web Randomization System (IWRS), included by not limited to screening, randomization, drug allocation,  submitted to the vendor for analysis.  May also include technical aspects of the system development. | Core (if applicable) | 5.5.3 |  | 141 | X | NO | X | NO | D | 22 | Manage Project / Manage IMP/Device | X
06 | IP and Trial Supplies | 06.06 | Interactive Response Technology | 06.06.02 | IRT Validation Certification |  | To confirm the validation status of the interactive response technology (IRT). | Core (if applicable) | 5.5.3 |  | 142 | X | NO | X | NO | D | 8 | Secure Resources / Vendors | X
06 | IP and Trial Supplies | 06.06 | Interactive Response Technology | 06.06.03 | IRT User Acceptance Testing (UAT) Certification | IRT UAT Scripts and Sign Off | To document the acceptability of the series of assessments  of the IRT performed by key users of the system that are designed to show that the IRT has been correctly programmed and meets the requirements of the User Requirements Specification (URS).  Minimally the signature page and may include validation or other documentation. | Core (if applicable) | 5.5.3 |  | 143 | X | NO | X | NO | D | 3 | Develop Study Design / Capture Subject Data | X
06 | IP and Trial Supplies | 06.06 | Interactive Response Technology | 06.06.04 | IRT User Manual |  | To provide instructions and define the operational instructions for the IRT for the user. | Core (if applicable) |  |  | 144 | X | XG  (if applicable) | X | XG  (if applicable) | D | 4 | Develop Study Design / Document Development | X
06 | IP and Trial Supplies | 06.06 | Interactive Response Technology | 06.06.05 | IRT User Notifications |  | To inform IRT Users of the following notifications of IVRS system access permissions for study management or site personnel, subject randomization number, IP request, IP shipments, etc. | Core (if applicable) |  |  | 145 | X | XS  (if applicable) | X | XS  (if applicable) | D | 22 | Manage Project / Manage IMP/Device | X
06 | IP and Trial Supplies | 06.07 | General | 06.07.01 | Relevant Communications | Correspondence | Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes. | Core | 8.3.11 |  | 146 | X | XS | X | XS | M | Per content |  | X | X | X
06 | IP and Trial Supplies | 06.07 | General | 06.07.02 | Tracking Information |  | Zone-specific documents developed for the purpose of tracking activities during the course of the trial. | Recommended |  |  | 147 | X | NO | X | NO | D | Per content |  | X | X | X
06 | IP and Trial Supplies | 06.07 | General | 06.07.03 | Meeting Material |  | Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting which documents any agreements or significant discussions.  Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material. | Core (if applicable) |  |  | 148 | X | NO | X | NO | D | 22 | Manage Project / Manage IMP/Device | X
06 | IP and Trial Supplies | 06.07 | General | 06.07.04 | Filenote | Note to File | To document any decision or to clarify any information relating to this zone. | Core (if applicable) |  |  | 149 | X | NO | X | NO | D | Per content |  | X | X | X
07 | Safety Reporting | 07.01 | Safety Documentation | 07.01.01 | Safety Management Plan | Safety Reporting Plan | To clearly define the end-to-end process for the ongoing safety evaluation for the investigational product; includes data to be collected, reporting objectives, and processes for a clinical trial.  Plan may include but is not limited to associated documents for quality management, safety database entry specifications and templates, and/or coding guidelines. | Core | 2.2 5.16.1 |  | 150 | X | NO | X | NO | M | 12 | Develop Trial Management Strategy | X
07 | Safety Reporting | 07.01 | Safety Documentation | 07.01.02 | Pharmacovigilance Database Line Listing | Periodic Line Listing | Listing of trial data used for a variety of safety evaluation of the investigational product purposes (e.g. Serious Adverse Events (SAE) case listings, database line listings, etc.). | Core | 5.16.1 5.17.3 8.3.17 |  | 151 | X | XS  (if applicable) | X | XS  (if applicable) | D | 28 | Manage Subject Risk / Report Safety Issue(s) | X | X
07 | Safety Reporting | 07.02 | Trial Status Reporting | 07.02.01 | Expedited Safety Report | CIOMS Report MedWatch Investigational New Drug (IND) Safety Report Suspected Unexpected Serious Adverse Reaction (SUSAR) Unanticipated Serious Adverse Device Event (USADE) Reporting Form | To assure notification by the sponsor of unexpected serious adverse drug reactions and other safety information; submitted to regulatory authorities and IRBs/IECs.   Reports may include but are not limited to CIOMS, USADE forms, MedWatch, Electronic Submission of AE Notification to FDA (E2B) Reports, Analysis of Similar Events, cover letters, and/or country-specific reporting forms. | Core (if applicable) | 5.16.2 5.17 8.3.17-18 |  | 152 | X | XG  (if applicable) | X | XG  (if applicable) | M | 28 | Manage Subject Risk / Report Safety Issue(s) | X |  | X
07 | Safety Reporting | 07.02 | Trial Status Reporting | 07.02.02 | SAE Report |  | To organize critical data around a serious adverse event, adverse event, and/or a laboratory abnormality as identified in the protocol.  Reports may include but are not limited to specific investigator SAE report forms and supporting data, reporter correspondence, associated note-to-files, source documentation, case logs, narratives, case unblinding forms, and/or safety database case printouts. | Core (if applicable) | 4.11 8.3.16 |  | 153 | X | XS  (if applicable) | X | XS  (if applicable) | M | 28 | Manage Subject Risk / Report Safety Issue(s) | X |  | X
07 | Safety Reporting | 07.02 | Trial Status Reporting | 07.02.03 | Pregnancy Report |  | To organize critical data around a pregnancy that occurred whilst either the male or the female subject was participating in a clinical trial. Reporting forms and supporting data collected for pregnancy cases and their outcome.  Reports may include but are not limited to specific regulatory forms and supporting data, reporter correspondence, associated note-to-files, source documentation, case logs, case unblinding form, narratives, and/or safety database case printouts. | Core (if applicable) | 4.11 8.3.16 |  | 154 | X | XS  (if applicable) | X | XS  (if applicable) | M (if applicable) | 28 | Manage Subject Risk / Report Safety Issue(s) |  |  | X
07 | Safety Reporting | 07.02 | Trial Status Reporting | 07.02.04 | Special Events of Interest | Medical Events of Interest | To organize critical data around a special event of interest, one that is of scientific and medical concern specific to the product or program.  Usually requested by or submitted to Regulatory Agencies.  Reports may include but are not limited to specific regulatory forms and supporting data, reporter correspondence, associated note-to-files, source documentation, case logs, narratives, case unblinding forms, and/or safety database case printouts. | Core (if applicable) |  |  | 155 | X | XS  (if applicable) | X | XS  (if applicable) | D | 29 | Manage Subject Risk / Manage Urgent Safety Measures | X |  | X
07 | Safety Reporting | 07.03 | General | 07.03.01 | Relevant Communications | Correspondence | Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes. | Core | 8.3.11 |  | 156 | X | XS | X | XS | M | 28 | Manage Subject Risk / Report Safety Issue(s) | X |  | X
07 | Safety Reporting | 07.03 | General | 07.03.02 | Tracking Information |  | Zone-specific documents developed for the purpose of tracking activities during the course of the trial. | Recommended |  |  | 157 | X | NO | X | NO | D | 21 | Manage Project / Report on Progress | X | X | X
07 | Safety Reporting | 07.03 | General | 07.03.03 | Meeting Material |  | Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting which documents any agreements or significant discussions.  Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material. | Core (if applicable) |  |  | 158 | X | NO | X | NO | D | 21 / 28 | Manage Project / Report on Progress / Manage Subject Risk / Report Safety Issue(s) | X
07 | Safety Reporting | 07.03 | General | 07.03.04 | Filenote | Note to File | To document any decision or to clarify any information relating to this zone. | Core (if applicable) |  |  | 159 | X | NO | X | NO | D | Per content |  | X |  | X
08 | Centralized Testing | 08.01 | Facility Documentation | 08.01.01 | Certification or Accreditation | Qualifications | To document recognition and approval by an authorized accrediting body applying known acceptable standards, that the facility is competent to perform required test(s), and support reliability of results; if applicable. | Core | 8.2.12 8.3.7 |  | 160 | X | XG | X | XG | D | 8 | Secure Resources / Vendors | X | X | X
08 | Centralized Testing | 08.01 | Facility Documentation | 08.01.02 | Laboratory Validation Documentation | Method validation, quality control testing, precision testing | To document through use of control data that a laboratory can consistently and reproducibly report results that are reliable; may include but is not limited to reporting of calibration and control results for a research test parameter, antibody or pharmacokinetic testing that may be performed by an internal or external laboratory; required if certification or accreditation is not available for the study test method. | Core (if applicable) | 8.2.12 8.3.7 |  | 161 | X | NO | X | NO | D | 8 | Secure Resources / Vendors | X | X | X
08 | Centralized Testing | 08.01 | Facility Documentation | 08.01.03 | Laboratory Results Documentation |  | Summary listings or individual subject reports provided by the laboratory or other testing facility, e.g. results of biochemical testing,  histological examination. | Core (if applicable) | 8.2.12 8.3.8 |  | 162 | X | XS | X | XS | D | 18 | Complete Subject Study Visit | X | X | X
08 | Centralized Testing | 08.01 | Facility Documentation | 08.01.04 | Normal Ranges | [NAME] | To define acceptable limits (where 95% of the population that a facility serves will fall) for comparative interpretation that allow for medical decisions to be made;  may be included in User Manual. | Core | 8.2.11 8.3.6 |  | 163 | X | XG | X | XG | D | 5 | Develop Study Design / Feasibility & Site Evaluation | X | X | X
08 | Centralized Testing | 08.01 | Facility Documentation | 08.01.05 | Manual | Facility Manual Facility Handbook Laboratory Manual | To outline the procedures to be followed in the collection, handling and shipping of samples; may not be available for local facilities. | Recommended | 8.2.14 |  | 164 | X | XG | X | XG | D | 4 | Develop Study Design / Document Development | X | X | X
08 | Centralized Testing | 08.01 | Facility Documentation | 08.01.06 | Supply Import Documentation |  | To provide the necessary documentation required per country to allow for importation of supplies (non-drug / IP). | Core (if applicable) | 8.2.15 8.3.8 |  | 165 | X | NO | X | NO | D | 22 | Manage Project / Manage IMP/Device | X | X | X
08 | Centralized Testing | 08.01 | Facility Documentation | 08.01.07 | Head of Facility Curriculum Vitae |  | To verify that the Head of Facility is suitably qualified to lead and oversee the management and reporting of results; may be included with Certification / Accreditation; may be found in the User Manual. | Recommended | 8.2.12 8.3.7 |  | 166 | X | NO | X | NO | D | 25 | Manage Project / Oversee Vendor(s) | X | X | X
08 | Centralized Testing | 08.01 | Facility Documentation | 08.01.08 | Standardization Methods | Interlaboratory Comparison Testing Proficiency Testing | To confirm that two or more facilities can perform the same test / procedure and obtain consistent results; includes but may not be limited to cross-calibration of test methods between assays or facilities or phantom data for CT or bioanalytical assay. | Core (if applicable) | 8.2.12 8.3.7 |  | 167 | X | NO | X | NO | D | 8 | Secure Resources / Vendors | X | X | X
08 | Centralized Testing | 08.02 | Sample Documentation | 08.02.01 | [NAME] | Sample Label | To capture critical information about the collection of a sample; may include but is not limited to subject ID, date and time of collection, etc; may be included in User Manual. | Recommended |  |  | 168 | X | NO | X | NO | D | 4 | Develop Study Design / Document Development | X | X | X
08 | Centralized Testing | 08.02 | Sample Documentation | 08.02.02 | Shipment Records | Specimen Shipment Records | To provide relevant details for samples sent in any one shipment. | Recommended | 8.2.15 8.3.8 |  | 169 | X | XS | X | XS | D | 22 | Manage Project / Manage IMP/Device | X | X | X
08 | Centralized Testing | 08.02 | Sample Documentation | 08.02.03 | Sample Storage Condition Log | Specimen Storage Condition Log | To monitor and track sample storage under the appropriate conditions. | Recommended | 8.2.14 |  | 170 | X | XS | X | XS | D | 22 | Manage Project / Manage IMP/Device | X | X | X
08 | Centralized Testing | 08.02 | Sample Documentation | 08.02.04 | Sample Export Documentation |  | To provide the necessary documentation required per country to allow for exportation of samples. | Core (if applicable) | 8.2.15 8.3.8 |  | 171 | X | NO-CS (if applicable) | X | NO-CS (if applicable) | D | 6 | Secure Resources / Supplies | X | X | X
08 | Centralized Testing | 08.02 | Sample Documentation | 08.02.05 | Record of Retained Body Fluids / Tissue Samples |  | To document location and identification of  samples being held for possible future (re)testing; to include destruction records, when and if this occurs. | Core (if applicable) | 8.3.25 |  | 172 | X | XS  (if applicable) | X | XS  (if applicable) | D | 20 | Manage Project | X | X | X
08 | Centralized Testing | 08.03 | General | 08.03.01 | Relevant Communications | Correspondence | Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes. | Core | 8.3.11 |  | 173 | X | XS | X | XS | D | Per content |  | X | X | X
08 | Centralized Testing | 08.03 | General | 08.03.02 | Tracking Information |  | Zone-specific documents developed for the purpose of tracking activities during the course of the trial. | Recommended |  |  | 174 | X | NO | X | NO | D | Per content |  | X | X | X
08 | Centralized Testing | 08.03 | General | 08.03.03 | Meeting Material |  | Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting which documents any agreements or significant discussions.  Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material. | Core (if applicable) |  |  | 175 | X | NO | X | NO | D | 6 | Secure Resources / Supplies | X | X
08 | Centralized Testing | 08.03 | General | 08.03.04 | Filenote | Note to File | To document any decision or to clarify any information relating to this zone. | Core (if applicable) |  |  | 176 | X | NO | X | NO | D | 20 | Manage Project | X | X | X
09 | Third parties | 09.01 | Third Party Oversight | 09.01.01 | Qualification and Compliance | Documentation of Decision to Utilize Third Party Qualification of Vendor Audit Certificate | To confirm that a third party meets, and continues to meet throughout the study, all relevant criteria to fulfill a contractual obligation; may include a quality questionnaire, a visit report to qualify their capabilities, other documents that support capabilities. | Core (if applicable) |  |  | 177 | X | NO | X | NO | D | 8 | Secure Resources / Vendors | X | X
09 | Third parties | 09.02 | Third Party Set-up | 09.02.01 | Confidentiality Agreement |  | To confirm by written legal agreement that key information between parties will be prevented from being inappropriately disclosed.  May be included in another contractual agreement. | Core (if applicable) | 1.16 |  | 178 | X | NO | X | NO | D | 8 | Secure Resources / Vendors | X | X
09 | Third parties | 09.02 | Third Party Set-up | 09.02.02 | Vendor Selection | Vendor Selection Documents | To identify how a third party will be chosen and the criteria to be used in the process. May include document provided as part of the process | Recommended |  |  | 179 | X | NO | X | NO | D | 8 | Secure Resources / Vendors | X | X
09 | Third parties | 09.02 | Third Party Set-up | 09.02.03 | Contractual Agreement | Scope of Work Project Work Order(s) Change Order(s) Financial Agreement Contract Service Agreement Letter of Agreement / Agreement Authorization to Proceed | To document by a written dated signed agreement between two or more parties that defines any arrangements on delegation and distribution of tasks and obligations; critical components include service description, responsibilities matrix and budget. | Core (if applicable) | 1.17 8.2.6 |  | 180 | X | NO | X | NO | D | 7 | Secure Resources / People | X | X
09 | Third parties | 09.02 | Third Party Set-up | 09.02.04 | Roles and Responsibilities Matrix | Task Ownership Matrix Transfer of Obligations Transfer of Regulatory Obligation Technical Agreement (for GMP) RACI | To identify range and distribution of tasks and responsibilities; may define internal assignment and all external parties; covers GCP as well as business process; often part of the Contractual Agreement. | Core (if applicable) | 5.2.2 5.7 |  | 181 | X | NO | X | NO | D | 8 | Secure Resources / Vendors | X | X
09 | Third parties | 09.03 | General | 09.03.01 | Relevant Communications | Correspondence | Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes. | Core (if applicable) | 8.3.11 |  | 182 | X | NO | X | NO | D | 25 | Manage Project / Oversee Vendor(s) | X | X
09 | Third parties | 09.03 | General | 09.03.02 | Tracking Information |  | Zone-specific documents developed for the purpose of tracking activities during the course of the trial. | Recommended |  |  | 183 | X | NO | X | NO | D | Per content |  | X | X
09 | Third parties | 09.03 | General | 09.03.03 | Meeting Material |  | Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting which documents any agreements or significant discussions.  Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material. | Core (if applicable) |  |  | 184 | X | NO | X | NO | D | 25 | Manage Project / Oversee Vendor(s) | X | X
09 | Third parties | 09.03 | General | 09.03.04 | Filenote | Note to File | To document any decision or to clarify any information relating to this zone. | Core (if applicable) |  |  | 185 | X | NO | X | NO | D | Per content |  | X | X
10 | Data Management | 10.01 | Data Management Oversight | 10.01.01 | Data Management Plan (Paper and EDC) | Data Management Operational Plan Data Handling Manual Data Processing Plan Technology Plan | To identify the overall strategy for data management process including responsibilities, procedures and deliverables:.   May be a compilation of documents that includes but is not limited to:  Completion Guidelines, Data Quality Plan, CRF Design Document,  Database (build) Specification, Entry Guidelines, Database Testing. Most if not all artifacts are listed in the Data Management zone. | Recommended | 5.1 5.5 | Data Management Plan | 186 | X | NO | X | NO | D | 20 | Manage Project | X
10 | Data Management | 10.02 | Data Capture | 10.02.01 | CRF Completion Requirements (Paper and EDC) | CRF Completion Guidelines | To provide detailed instructions on how data points on each CRF are to be completed; how to enter on paper and if EDC, how to enter data into the system. | Core | 2.10 4.9.1 4.9.2 |  | 187 | X | XG | X | XG | M | 3 | Develop Study Design / Capture Subject Data | X | X
10 | Data Management | 10.02 | Data Capture | 10.02.02 | Annotated CRF (Paper and EDC) |  | To assign variable names and attributes to the fields on the CRF, and to link the variables to the tables within the database; may also be used as an aid for database programming on how to structure the database; use for data extraction; may be generated at the time of regulatory submission. | Recommended | 5.1 | Annotated CRF | 188 | X | NO | X | NO | D | 18 | Complete Subject Study Visit | X
10 | Data Management | 10.02 | Data Capture | 10.02.03 | Completed CRFs (Paper) |  | Documents which contain the available protocol-required information reported to the sponsor for each subject in the clinical trial; associated documents may include but are not limited to documentation of CRF corrections, subject diaries, questionnaires, laboratory reports and other third-party specialty data. | Core | 4.9.3 5.5 8.3.14 |  | 189 | X | XS | X | XS | D | 20 | Manage Project |  |  | X
10 | Data Management | 10.02 | Data Capture | 10.02.04 | Documentation of Corrections to Entered Data (Paper) | Data Clarification Forms Data Correction Forms Data Query Forms | Any documentation used to query database discrepancies and to record approved corrections to the clinical trial database; may include self-evident corrections, global queries, SAE queries, laboratory queries and any other database queries generated. | Core | 4.9.3 8.3.15 |  | 190 | X | XS | X | XS | D | 20 | Manage Project |  |  | X
10 | Data Management | 10.02 | Data Capture | 10.02.05 | Final Data (EDC output) | Final Casebooks; Final Subject Reports | Final EDC data for the protocol, and a copy of each site's by-subject data which is sent to the site for approval and retention. | Core (if applicable) | 8.3.14 4.9.4 |  | 191 | X | XS  (if applicable) | X | XS  (if applicable) | D | 20 | Manage Project |  |  | X
10 | Data Management | 10.03 | Database | 10.03.01 | Database Specifications (Paper) | Database Programming Requirements | To provide a detailed framework for the database to be built for paper CRF data capture system. | Core | 1.46 5.1 5.5 |  | 192 | X | NO | X | NO | D | 3 | Develop Study Design / Capture Subject Data | X
10 | Data Management | 10.03 | Database | 10.03.02 | Edit Check Plan (Paper) | Edit Check & Logic Check Specifications | Specifications which will detect data that is illogical, unexpected, missing, redundant, or is outside of defined study parameters; usually implemented via programming logic | Core | 5.1 5.5 |  | 193 | X | NO | X | NO | D | 12 | Develop Trial Management Strategy | X
10 | Data Management | 10.03 | Database | 10.03.03 | Edit Check Programming (Paper) |  | The computer code which satisfies the edit check plan/specification details; may include a reference to where the code resides. | Core | 5.1 5.5 |  | 194 | X | NO | X | NO | D | 3 | Develop Study Design / Capture Subject Data | X
10 | Data Management | 10.03 | Database | 10.03.04 | Edit Check Testing (Paper) | Edit Check  QC | To provide evidence that the data edit checks have been implemented correctly; can include the data used to test the programming logic | Core | 5.1 5.5 |  | 195 | X | NO | X | NO | D | 12 | Develop Trial Management Strategy | X
10 | Data Management | 10.03 | Database | 10.03.05 | Approval for Database Activation (Paper and EDC) | Database Release Approval Report; Go-Live Approval Form; Push-to-Production Form | Documentation that all requirements of the database specification have been satisfied, and data entry can begin (go live); will also include confirmation that edit check testing and UAT (user acceptance testing) has been successfully completed. May include a modified version to activate implementation of change control | Core | 5.1 5.5 |  | 196 | X | NO | X | NO | D | 12 | Develop Trial Management Strategy | X
10 | Data Management | 10.03 | Database | 10.03.06 | External Data Transfer Specifications (Paper and EDC) |  | To document import and export data specifications; includes but is not limited to diary, lab, IVRS, imaging; may include transfer from one group to another. | Core (if applicable) | 5.1 5.5 |  | 197 | X | NO | X | NO | D | 20 | Manage Project | X
10 | Data Management | 10.03 | Database | 10.03.07 | Data Entry Guidelines (Paper) |  | To provide detailed instructions on how CRF data is to be entered into a database; specific to a paper CRF trial (therefore, would not be required with an EDC trial), including self-evident corrections and global conventions. | Core (if applicable) | 5.1 5.5 |  | 198 | X | NO | X | NO | D | 3 | Develop Study Design / Capture Subject Data | X
10 | Data Management | 10.03 | Database | 10.03.08 | SAE Reconciliation (Paper and EDC) |  | To document reconciliation and resolution of discrepancies between the SAEs in the safety and the clinical databases has been successfully completed. | Core | 5.1 5.5 |  | 199 | X | NO | X | NO | D | 20 | Manage Project | X
10 | Data Management | 10.03 | Database | 10.03.09 | Dictionary Coding  (Paper and EDC) | Medical Coding | To document the tools used in medical coding and the final coded terms; includes medical sign off of coding; may include resolution discrepancies. | Core | 5.1 5.5 |  | 200 | X | NO | X | NO | D | 12 | Develop Trial Management Strategy | X
10 | Data Management | 10.03 | Database | 10.03.10 | Data QC / QA Plan & Results (Paper and EDC) | QC/QA Data Documentation | To define the procedures for creating and implementing a Quality Control (QC) Plan to ensure that quality data is captured into a clinical database on an ongoing basis.  This would include any documentation of the results from the plan. | Core | 5.1 5.5 |  | 201 | X | NO | X | NO | D | 20 | Manage Project | X
10 | Data Management | 10.03 | Database | 10.03.11 | Database Lock and Unlock Approval (Paper and EDC) |  | Confirmation that all of the requirements for database release have been meet; may include all unlock and re-lock documentation as well as a report on data quality issues and summary of essential activities prior to database lock | Core | 5.1 5.5 |  | 202 | X | NO | X | NO | D | 20 | Manage Project | X
10 | Data Management | 10.03 | Database | 10.03.12 | Database Change Control (Paper and EDC) |  | Summary of requested change, reason for change,  relevant approvals, impact / risk analysis, associated requirements, specifications and other documentation describing the validation and implementation of this change. | Core | 5.1 5.5 |  | 244 | X | NO | X | NO | D | 20 | Manage Project | X
10 | Data Management | 10.04 | EDC Management | 10.04.01 | System Account Management |  | To capture account management details for all users who received access to the system; should include security role, date account granted, date account disabled. | Core (if applicable) | 5.5.3 (d) and (e) |  | 204 | X | XS  (if applicable) | X | XS  (if applicable) | D | 16 | Set up site(s) | X |  | X
10 | Data Management | 10.04 | EDC Management | 10.04.02 | Technical Design Document | EDC System Specifications Core Configuration Specifications | Document containing  the design elements of the eCRF including the variables to be collected, the logical arrangement of the variables, navigation among and between the different forms, the logic checks for logical consistency | Core (if applicable) | 5.5.3 |  | 245 | X | XS  (if applicable) | X | XS  (if applicable) | D | 16 | Set up site(s) | X |  | X
10 | Data Management | 10.04 | EDC Management | 10.04.03 | Validation Documents |  | Documents establishing the project context and documentation requirments; can include the plan for, and results of, the user acceptance testing (UAT). Includes the validation report to provide wrap up and post go-live summary if required. | Core (if applicable) | 5.5.1 5.5.3 |  | 246 | X | XS  (if applicable) | X | XS  (if applicable) | D | 16 | Set up site(s) | X |  | X
10 | Data Management | 10.05 | General | 10.05.01 | Relevant Communications | Correspondence | Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes. | Core | 8.3.11 |  | 205 | X | NO | X | NO | D | 20 | Manage Project | X | X | X
10 | Data Management | 10.05 | General | 10.05.02 | Tracking Information |  | Zone-specific documents developed for the purpose of tracking activities during the course of the trial. | Recommended |  |  | 206 | X | NO | X | NO | D | Per content |  | X |  | X
10 | Data Management | 10.05 | General | 10.05.03 | Meeting Material |  | Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting which documents any agreements or significant discussions.  Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material. | Core (if applicable) |  |  | 207 | X | NO | X | NO | D | 20 | Manage Project | X
10 | Data Management | 10.05 | General | 10.05.04 | Filenote | Note to File | To document any decision or to clarify any information relating to this zone. | Core (if applicable) |  |  | 208 | X | NO | X | NO | D | 20 | Manage Project | X | X | X
11 | Statistics | 11.01 | Statistics Oversight | 11.01.01 | Statistical Analysis Plan | SAP | To define, in detail, the statistical aspects of the trial design, the process of data selection for all analyzes, the data items to be analyzed and all the procedures and methods to be employed in the analysis of those data items as well as the planned presentation of those results (Tables, Listings and Figures (TLFs)). Includes interim and final. | Core | 6.9 | Statistical Analysis Plan | 209 | X | NO | X | NO | M | 12 | Develop Trial Management Strategy | X
11 | Statistics | 11.01 | Statistics Oversight | 11.01.02 | Sample Size Calculation |  | To document the technique, assumptions and output used to calculate the sample size; can include QC and sign off. | Core |  |  | 210 | X | NO | X | NO | D | 12 | Develop Trial Management Strategy | X
11 | Statistics | 11.02 | Randomization | 11.02.01 | Randomization Plan |  | To detail the randomization scheme (e.g number and name of treatments, strata, block size) and how the randomization will be carried out; this plan is then used to initiate programming. | Core | 4.7 6.4.2 |  | 211 | X | NO | X | NO | M | 12 | Develop Trial Management Strategy | X
11 | Statistics | 11.02 | Randomization | 11.02.02 | Randomization Procedure |  | To define the actual steps for how subjects are randomized in a trial.  This could be by interactive response technology (IRT)/IVRS, or a manual process ((i.e. work instruction). May be part of the randomization plan. | Core |  |  | 212 | X | NO | X | NO | M | 4 | Develop Study Design / Document Development | X
11 | Statistics | 11.02 | Randomization | 11.02.03 | Master [NAME] | Randomization Schedule | The single source on the assignment of subjects to protocol specified groups.   In blinded studies, this list remains blinded until its release following the final data lock. | Core | 8.2.18 |  | 213 | X | NO | X | NO | M | 20 | Manage Project | X
11 | Statistics | 11.02 | Randomization | 11.02.04 | Randomization Programming |  | Computer code to generate randomization number for treatment assignment. | Core | 5.4.1 |  | 214 | X | NO | X | NO | D | 12 | Develop Trial Management Strategy | X
11 | Statistics | 11.02 | Randomization | 11.02.05 | [NAME] | Randomization Approval | To verify that the randomization program generates the randomization number and treatment assignment correctly according to the randomization schema specified for the trial. | Core | 5.1.1 |  | 215 | X | NO | X | NO | D | 12 | Develop Trial Management Strategy | X
11 | Statistics | 11.02 | Randomization | 11.02.06 | End of Trial / Interim Unblinding | Decoding Request Randomization Release Request | To document and authorize the release of the randomization code and allow the trial data to be unblinded. Includes evidence of release of end of trial unblinding | Core | 5.1 5.5 |  | 216 | X | NO | X | NO | D | 30 | Manage Subject Risk / Break Blind | X
11 | Statistics | 11.03 | Analysis | 11.03.01 | Data Definitions for Analysis Datasets |  | To define the programming logic required to transform the raw dataset to the analysis dataset; includes populations, etc; as outlined in the SAP. | Core | 5.1 5.5 |  | 217 | X | NO | X | NO | D | 20 | Manage Project | X
11 | Statistics | 11.03 | Analysis | 11.03.02 | Analysis QC Documentation |  | To confirm the QC procedures planned for the analysis programs as well as the actual output of the QC steps. | Core | 5.1 5.5 |  | 218 | X | NO | X | NO | D | 12 | Develop Trial Management Strategy | X
11 | Statistics | 11.03 | Analysis | 11.03.03 | Interim Analysis Raw Datasets |  | The export of raw data for interim analysis purposes. | Core (if applicable) | 5.1 5.5 |  | 219 | X | NO | X | NO | D | 36 | Analyse Data / Interim Data Analysis | X
11 | Statistics | 11.03 | Analysis | 11.03.04 | Interim Analysis Programs |  | The suite of programs designed to  generate the interim analysis outputs as referenced in the SAP. | Core (if applicable) |  |  | 220 | X | NO | X | NO | D | 4 | Develop Study Design / Document Development | X
11 | Statistics | 11.03 | Analysis | 11.03.05 | Interim Analysis Datasets |  | The datasets used for the interim analyses. | Core (if applicable) |  |  | 221 | X | NO | X | NO | D | 36 | Analyse Data / Interim Data Analysis | X
11 | Statistics | 11.03 | Analysis | 11.03.06 | Interim Analysis Output |  | The Tables Listings and Figures produced from the interim analysis datasets; includes Statistics approval. | Core (if applicable) |  |  | 222 | X | NO | X | NO | D | 36 | Analyse Data / Interim Data Analysis | X
11 | Statistics | 11.03 | Analysis | 11.03.07 | Final Analysis Raw Datasets |  | The export of raw data for final analysis purposes. | Core |  | Datasets | 223 | X | NO | X | NO | D | 37 | Analyse Data / Final Data Analysis | X
11 | Statistics | 11.03 | Analysis | 11.03.08 | Final Analysis Programs |  | The suite of programs designed to  generate the final analysis outputs as referenced in the SAP. | Core |  | Program File for Analysis Dataset | 224 | X | NO | X | NO | D | 4 | Develop Study Design / Document Development | X
11 | Statistics | 11.03 | Analysis | 11.03.09 | Final Analysis Datasets |  | The datasets used for the final analysis. | Core |  | Analysis Datasets | 225 | X | NO | X | NO | D | 37 | Analyse Data / Final Data Analysis | X
11 | Statistics | 11.03 | Analysis | 11.03.10 | Final Analysis Output |  | The Tables, Listings and Figures produced from the final analysis datasets; includes Statistics approval. May be appended to the CSR. | Core |  | Statistical Output | 226 | X | NO | X | NO | M | 37 | Analyse Data / Final Data Analysis | X
11 | Statistics | 11.03 | Analysis | 11.03.11 | Subject Evaluability Criteria & Subject Classification | Population Definition Criteria Protocol Violations Deviations and Exemptions Protocol Deviation Listing | To document the decisions which define the criteria applied to evaluate each subject in the trial, in order to that will unambiguously assign the subject to the populations established in the SAP. | Core | 6.9.7 | Protocol Deviation Listing | 227 | X | NO | X | NO | M | 36 | Analyse Data / Interim Data Analysis | X
11 | Statistics | 11.04 | Report | 11.04.01 | Interim Statistical Report(s) |  | To summarize the relevant statistical aspects of the interim analysis.  May be appended to the CSR. | Core (if applicable) | 5.1 5.5 |  | 228 | X | NO | X | NO | D | 40 | Report Data / Write Reports | X
11 | Statistics | 11.04 | Report | 11.04.02 | Statistical Report |  | To summarize the relevant statistical aspects of the final analysis.  May be appended to the CSR. | Core | 5.1 5.5 |  | 229 | X | NO | X | NO | D | 37 | Analyse Data / Final Data Analysis | X
11 | Statistics | 11.05 | General | 11.05.01 | Relevant Communications | Correspondence | Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes. | Core | 8.3.11 |  | 230 | X | NO | X | NO | D | Per content |  | X
11 | Statistics | 11.05 | General | 11.05.02 | Tracking Information |  | Zone-specific documents developed for the purpose of tracking activities during the course of the trial. | Recommended |  |  | 231 | X | NO | X | NO | D | 21 | Manage Project / Report on Progress | X
11 | Statistics | 11.05 | General | 11.05.03 | Meeting Material |  | Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting which documents any agreements or significant discussions.  Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material. | Core (if applicable) |  |  | 232 | X | NO | X | NO | D | 37 | Analyse Data / Final Data Analysis | X
11 | Statistics | 11.05 | General | 11.05.04 | Filenote | Note to File | To document any decision or to clarify any information relating to this zone. | Core (if applicable) |  |  | 233 | X | NO | X | NO | D | 20 | Manage Project | X