Essential documents checklist: Title Of Document Purpose Investigator File TMF Sponsor File Comment Where applicable, any translations and back translations of essential documents To clarify documents have been translated, and to provide evidence that the translation was appropriate. X X (if related to documents kept in Sponsor File) Risk assessment documentation To document the process and outcome of risk assessment, and how this informed the trial set up and management. X Any and guidelines, e.g. Monitor Plan, Communication Plan, Statistical Analysis Plan To document the systems put in place to address trial risks and to ensure quality data is generated and the subjects’ safety and wellbeing is safeguarded. X Investigator’s Brochure or Summary of Products Characteristics and updates To document that relevant and current scientific information about the investigational product has been provided to the investigator X X Signed Protocol and amendments, if any, and sample Case Report Form (CRF) and any revisions To document investigator and sponsor agreement to the protocol/amendment(s) and CRF X (PI signed) X (PI and CI signed) X (unsigned) Information given to trial subject and any revisions thereof: - Master Informed Consent Form To document the informed consent X X X - Any other written information To document that subjects will be given appropriate written X X X
information (content and 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 (where 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 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
Sample of label(s) attached to Investigational Product container(s) To document compliance with applicable labelling regulations and appropriateness of instructions provided to the subjects X 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 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 trial,
Signed, dated 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 corrections made to CRF after initial data were recorded X (copy) X (original) 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, applicable, to regulatory authorities and IRB(s)/IEC(s) of unexpected serious adverse drug reactions and of other safety information X 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