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

ICH E6(R3) Guideline

(c) Once the trial has been unblinded and relevant analyses/conclusions have been completed and finalised, the sponsor should generally, in accordance with applicable regulatory requirements:

(i)

Make trial results publicly available;

(ii)

Provide the investigator with information about the treatment taken by their participants for blinded trials;

(iii) Provide investigators with the trial results. Where a summary of trial results is provided to participants, this should have language that is non-technical, understandable to a layperson and non-promotional.

4.

DATA GOVERNANCE – INVESTIGATOR AND SPONSOR

This section provides guidance to the responsible parties (i.e., investigators and sponsors) on appropriate management of data integrity, traceability and security, thereby allowing the accurate reporting, verification and interpretation of the clinical trial-related information. This section should be read in conjunction with corresponding responsibilities for the investigator and the sponsor as defined in sections 2 and 3, along with ICH E8(R1), ICH E9 and ICH E9(R1). The quality and amount of the information generated in a clinical trial should be sufficient to address trial objectives, provide confidence in the trial’s results and support good decision making.

The systems and processes that help ensure this quality should be designed and implemented in a way that is proportionate to the risks to participants and the reliability of trial results.

The following key processes should address the full data life cycle with a focus on the criticality of the data and should be implemented proportionately and documented appropriately:

(a) Processes to ensure the protection of the confidentiality of trial participants’ data;

(b) Processes for managing computerised systems to ensure that they are fit for purpose and used appropriately;

(c) Processes to safeguard essential elements of the clinical trial, such as randomisation, dose adjustments and blinding;

(d) Processes to support key decision making, such as data finalisation prior to analysis, unblinding, allocation to analysis data sets, changes in clinical trial design and, where applicable, the activities of, for example, an IDMC.

4.1

Safeguard Blinding in Data Governance

4.1.1

Maintaining the integrity of the blinding is important in particular in the design of systems, management of users ’ account s, delegation of responsibilities with respect

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