wording) to support their ability to give fully informed consent - Advertisement for subject recruitment (if used) To document that recruitment measures are appropriate and not coercive X X X Financial aspects of the trial (including funding application/award letter) To document the financial agreement between the investigator/institution and the sponsor for the trial X X (auto) Insurance statement required; for CTIMPs insurance/indemnity cover is a legal requirement) To document that compensation to subject(s) for trial-related injury will be available X X X (auto) Signed Agreement between involved parties, e.g.: Investigator/Institution and Sponsor (Clinical Trial Site Agreements) To document agreements X X X Investigator/Institution and third parties, eg. Vendors, coordinating centre etc To document agreements X X (where required) X Charter signed by Data Monitoring Committee members To document expectations of both parties, e.g. via a charter X Sponsor and Chief Investigator To document expectations of both parties, e.g. via CI Declaration Form or CI Agreement X X
Letter of Sponsorship To document that the Sponsor has agreed to take on Sponsorship responsibilities for the trial X X X(auto) Dated, documented Favourable Opinion of Research Ethics Committee (REC) of the following including any revisions: Protocol and any amendments Informed Consent Form(s) Any other written information to be provided to the subject(s) Advertisement for subject recruitment (if used) Subject compensation (if any) Any other documents given Approval/ Favourable Opinion Along with REC composition for each Favourable Ethical Opinion To document that the trial has been subject to REC review and given favourable opinion. To identify the version number and date of the document(s). To document that the favourable opinion is maintained throughout the trial. Documents include the application form and correspondence. X X X NHS permissions (if applicable) including application, approval letter and correspondence To document NHS permission was gained for an individual NHS site to participate in the trial X X X Regulatory Authority(ies) Clinical Trial Authorisation, including maintaining To document appropriate authorisation by the regulatory authority(ies) has been obtained prior to initiation of X X X
authorised to make entries and/or corrections on CRFs This may be combined with the delegation of responsibilities log. Delegation of responsibilities log To document what duties have been delegated by the site PI to site staff. This may be combined with the Signature Sheet. X X Normal for medical/laboratory/technical procedure(s) and/or test(s) included in the Protocol, including any updates To document normal values and/or ranges of the tests X X Medical/laboratory/technical procedures/tests, including any updates certification or accreditation or established quality control and/or external quality assessment or - other validation (where required) To document competence of facility to perform required test(s), and support reliability of results X X Record of retained body fluids/ tissue samples (if any) To document location and identification of retained samples if assays need to be repeated X X Sample of label(s) attached to Investigational Product container(s) To document compliance with applicable labelling regulations and appropriateness of X
instructions provided to the subjects Instructions for handling of Investigational Product(s) and trial-related materials and any updates (If not included in Protocol or Investigator’s Brochure) To document instructions needed to ensure proper storage, packaging, dispensing and disposition of investigational products and trial-related materials X X Shipping records for Investigational Product(s) and trial-related materials and any updates* To document shipment dates, batch numbers and method of shipment of investigational product(s) and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability X X Certificate(s) of Analysis of Investigational Product(s) shipped including Certificates of Analysis for new batches and QP release To document identity, purity, and strength of investigational product(s) to be used in the trial X Proof of Investigational Product(s) storage condition monitoring* To document that the required storage conditions of the Investigational Product(s) are maintained at site. Note that this is especially important where storage conditions vary from normal practice, e.g. use of refrigerator/freezer. X X Investigational Product(s) accountability at site * To document that the investigational product(s) have been used according to the protocol. To documents the X X
Up to date Subject Identification Code List To permit identification of all subjects enrolled in the trial by investigator/institution in case follow-up is required. List should be kept in a confidential manner and for agreed upon time. X Subject Enrolment Log To document chronological enrolment of subjects by trial number X Signed Informed Consent Forms To document that consent is obtained in accordance with GCP and protocol and prior to participation of each subject in trial. Also to document direct access permission X X (where applicable) Source Documents To document the existence of the subject and substantiate integrity of trial data collected. To include original documents related to the trial, to medical treatment, and history of subject X Sample Case Report Forms and any updates thereof To record trial related observations. X X Signed, and completed Case Report Forms (CRF) To document that the investigator or authorised member of the investigator’s staff confirms the observations recorded X (copy) X (original) Documentation of CRF corrections To document all changes/additions or X (copy) X (original)
corrections made to CRF after initial data were recorded Notification by originating Investigator to Sponsor of Serious Adverse Events and related reports Notification by originating investigator to sponsor of serious adverse events and related reports X X Notification by Sponsor and/or Investigator, where applicable, to Regulatory Authority(ies) and REC(s) of Unexpected Serious Adverse Drug Reactions (in CTIMPs: SUSARs) and of other safety information Notification by sponsor and/or investigator, where applicable, to regulatory authorities and IRB(s)/IEC(s) of unexpected serious adverse drug reactions and of other safety information X (where required) X X Notification by Sponsor to Investigators of safety information Notification by sponsor to Investigator of safety information. X X Final report by Investigator to REC where required, and where applicable, to the Regulatory Authority(ies) To document completion of the trial X X End of Study Declarations submitted to Authority and REC at the end of the trial To document completion of the trial X X Clinical Study Report To document results and interpretation of trial X (if applicable) X X Notes: * Many non-commercial trials use pharmacy supplies of medicinal products that have a marketing authorisation and the tracking of product batches, shipping conditions and accountability, storage and dispensing instructions and the need for reconciliation between medicinal products supplied, used and returned