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

ICH E6(R3) Guideline

(d) The sponsor should ensure that data acquisition tools are fit for purpose and designed to capture the information required by the protocol. They should be validated and ready for use prior to their required use in the trial.

(e) The sponsor should ensure that documented processes are implemented to ensure the data integrity for the full data life cycle (see section 4.2).

(f) The sponsor should implement measures to ensure the safeguarding of the blinding, if any (e.g., maintain the blinding during data entry and processing).

(g) The sponsor should put procedures in place to describe unblinding, where applicable; these descriptions should include:

(i)

Who were unblinded, at what timepoint and for what purpose they were unblinded;

(ii)

Who should remain blinded;

(iii)

The safeguards in place to preserve the blinding.

(h) The sponsor should provide guidance to investigators/institutions, service providers and trial participants, where relevant, on the expectations for data capture, data changes, data retention and data disposal. (i) The sponsor should not make changes to data entered by the investigator or trial participants unless justified, agreed upon in advance by the investigator and documented. (j) The sponsor should allow correction of errors to data, including data entered by participants, where requested by the investigators/participants. Such data corrections should be justified and supported by source records around the time of original entry. (k) The sponsor should ensure that the investigator has timely access to data collected in accordance with the protocol during the course of the trial, including relevant data from external sources (e.g., central laboratory data, centrally read imaging data and, if appropriate, ePRO data). This enables the investigators to make decisions (e.g., on eligibility, treatment, continuing participation in the trial and care for the safety of the individual trial participants) (see section 2.12.3). The sponsor should not share data that may unblind the investigator and should include the appropriate provisions in the protocol.

(l) The sponsor should not have exclusive control of data captured in data acquisition tools in order to prevent undetectable changes.

(m) The sponsor should ensure that the investigator has access to the required data for retention purposes.

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