ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

(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.

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