C.3.1 The assessment of whether a record is essential and has to be retained should take into account the criteria below. Such assessment, whilst important, is not required to be documented. A structured content list for storage repository(ies) may be used to prospectively identify essential records. An essential record:
(a) Is a document that is submitted to or issued by the regulatory authority or IRB/IEC, including related correspondence and those documenting regulatory decisions or approvals/favourable opinions;
(b) Is a trial-specific procedure or plan;
(c) Is relevant correspondence or documentation of meetings related to important discussions and/or trial-related decisions that have been made related to the conduct of the trial and the processes being used;
(d) Documents the conduct of relevant trial procedures (e.g., database lock checklist produced from following data management standard operating procedures (SOPs));
(e) Documents the arrangements between parties and insurance/indemnity arrangements;
(f) Documents the compliance with the requirements and any conditions of approval from the regulatory authority or the favourable opinion of the IRB/IEC;
(g) Documents the composition and, where appropriate, the functions, correspondence and decisions of any committees involved in the trial approval or its conduct.
(h) Demonstrates that a trial-specific computerised system is validated and that non-trial- specific systems (e.g., clinical practice computerised systems) have been assessed as fit for purpose for their intended use in the trial;
(i) Is a document that has been authorised/signed by the sponsor and/or investigator to confirm review or approval;
(j) Is, where necessary, documentation that demonstrates signatures/initials of staff undertaking significant trial-related activities; for example, completing data acquisition tools;
(k) Documents what information was provided to potential trial participants and that participants’ informed consent was appropriately obtained and maintained;
(l) Documents that sponsor personnel involved in the trial conduct and individuals performing significant trial-related activities on their behalf are qualified by education, training and experience to undertake their activities;
(m) Documents that the investigator and those individuals delegated significant trial-related activities by the investigator are qualified by education, training and experience to undertake their activities, particularly where the activities are not part of their normal role;
(n) Contains the data as well as relevant metadata that would be needed to allow the appropriate evaluation of the conduct of the trial;
(o) Is a document related to the sponsor or investigator oversight of trial participant safety during the trial, including compliance with safety reporting requirements between sponsors and investigators, regulatory authorities and IRBs/IECs and informing trial participants of safety information as necessary;
(p) Documents that service providers are suitably qualified for conducting their delegated or transferred activities;
(q) Documents that laboratory activities and other tests used in the trial are fit for purpose;
(r) Documents sponsor oversight of investigator site selection and monitoring and audit of the trial, where appropriate, and provides information on arising issues/noncompliance and deviations detected and implementation of corrective and preventative actions;
(s) Documents the compliance with the protocol and/or procedures for management and statistical analysis of the data and production of any interim report and the final report;
(t) Documents the collection, chain of custody, processing, analysis and retention or destruction of biological samples;
(u) Provides relevant information on the investigational product and its labelling;
(v) Provides information about the shipment, storage, packaging, dispensing, randomisation and blinding of the investigational product;
(w) Provides, where appropriate, traceability and accountability information about the investigational product from release from the manufacturer to dispensation, administration to trial participants, return and destruction or alternative disposition;
(x) Provides information on the identity and quality of the investigational product used in the trial;
(y) Documents processes and activities relating to unblinding;
(z) Documents the recruitment, pre-trial screening and consenting process of trial participants and their identity and chronological enrolment as appropriate;
(aa) Documents the existence of the trial participants and substantiates the integrity of trial data collected. Includes source records related to the trial and medical treatments and history of the trial participants;
(bb) Defines processes/practices in place in the event of a security breach in order to protect participants’ rights, safety and well-being and the integrity of the data.
C.3.2 Applying the criteria in section C.3.1, the trial records that are considered essential are listed in the Essential Records Table, and these should be retained when produced. This table is not an exhaustive list, and other trial records may also be considered essential by the sponsor or the investigator.
C.3.3 For some trial records listed in the Essential Record Table, their presence and nature are dependent on the trial design, trial conduct and risk proportionate management of the trial and may not be produced.