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 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 authorisation following changes to the trial. required) To document appropriate authorisation by the regulatory authority(ies) has been obtained to initiation of the trial in compliance with the applicable regulatory requirement(s), and to document that the authorisation is maintained throughout the trial. Documents include the application form and correspondence. X X X Other relevant approvals, e.g. ARSAC, HBRC including maintaining approval following changes to the trial. application forms, approval letters and correspondence, (where required) To document any other appropriate approvals has been obtained prior to initiation, and to document that the authorisation is maintained throughout the trial. Documents include the application form and correspondence. X X X Interim or Annual Reports to REC and Authority(ies) (where required) Interim or annual reports provided to REC in accordance with 4.10 (ICH GCP) and to authority(ies) X X X Curriculum Vitae and/or other relevant documents evidencing qualifications of Investigator(s) and Sub-Investigator(s) including To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects This includes GCP training. It is recommended that X X X (CI only)
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 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 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. X X
Sample Case Report Forms and any updates thereof To record trial related observations. X X 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 initial data were recorded X (copy) X (original) Analytical data and supporting records relating to clinical trial analysis To enable the conduct and quality of the data to be evaluated to ensure that the research has been conducted in accordance with GCP and all applicable regulations. X 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