- Advertisement for subject recruitment (if used) To document that recruitment measures are appropriate and not coercive X X X Financial aspects of the study (including funding application/award letter) To document the financial agreement between the investigator/institution and the sponsor for the study X X (auto) Insurance statement (where required) To document that compensation to subject(s) for study-related injury will be available X X X (auto) Signed Agreement between involved parties, e.g.: Investigator/Institution and Sponsor (Clinical Study Site Agreements) To document agreements X X X Where applicable, directed by Sponsor Investigator/Institution and third parties, eg. Vendors, coordinating centre etc To document agreements X X (where required) X Where applicable 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 study X X X(auto)
updates certification or accreditation or established quality control and/or external quality assessment or - other validation (where required) test(s), and support reliability of results 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 Where applicable Instructions for handling materials and any updates (If not included in Protocol) To document instructions needed to ensure proper storage, packaging, dispensing and disposition of study-related materials X X Where applicable Shipping records for study-related materials and any updates* To document shipment dates, batch numbers and method of shipment of study-related materials. Allows tracking of product batch, review of shipping conditions, and accountability X X Where applicable Certificate(s) of Analysis of Investigational Product(s) shipped including Certificates of Analysis for new batches To document identity, purity, and strength of study materials to be used in the study X Where applicable Proof of storage condition monitoring* To document that the required storage conditions of the study materials are maintained at site. Note that this is especially X X Where applicable related
important where storage conditions vary from normal practice, e.g. use of refrigerator/freezer. Investigational Product(s) accountability at site * To document that the study materials have been used according to the protocol. To documents the final accounting of material received at the site, dispensed to subjects, returned by the subjects, and returned to sponsor X X Where applicable Documentation of Investigational Product destruction* To document destruction of unused material by sponsor or at site X (if destroyed at site) X Where applicable Decoding procedures for blinded studies To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking the blind for the remaining subjects' treatment X X (third party if applicable) Where applicable Master Randomisation List To document method for randomisation of study population Note this may be a programme rather than a list, and may be held by the Study Statistician. In this case, a Note to File should be added to the TMF, document the name and contact details of the Study Statistician, and the parameters of the randomisation. X (third party if applicable) Where applicable
Investigator to Sponsor of Serious Adverse Events and related reports serious adverse events and related reports Notification by Sponsor and/or Investigator, where applicable, to Regulatory Authority(ies) and REC(s) of Unexpected Serious Adverse Drug Reactions 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 study X X End of Study Declarations submitted to Authority and REC at the end of the study To document completion of the study X X Clinical Study Report To document results and interpretation of study X (if applicable) X X Notes: Columns marked ‘X (auto)’: the underlying processes are dealt with by the UoB central offices (Research Governance Team, Research Finance Office) and the information will be automatically captured in the Sponsor Files.