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In case of data integrity issues or serious GCP non-compliance, is it necessary to notify regulatory authorities?
Ameya Bhatkal
In case of serious GCP non-compliance, GCP guidelines recommend that the sponsor should promptly notify the regulatory authorities.
ICH GCP 5.20 Non-compliance
5.20.2 - If the monitoring and/or auditing identifies serious and/or persistent noncompliance on the part of an investigator/institution, the sponsor should terminate the investigator's/ institution’s participation in the trial. When an investigator's/institution’s participation is terminated because of non-compliance, the sponsor should notify promptly the regulatory authority(ies).
Indian GCP 3.1.14. Audit
Sponsor should initiate prompt action in case it is discovered that any party involved has not entirely complied with the GCP, SOPs, Protocol and/or any applicable regulatory requirements. If monitoring/auditing identifies serious and/or persistent non-compliance - the sponsor should terminate the defaulting party’s participation in the study and promptly notify to the regulatory authority.
Is it acceptable per GCP, to simply place a Note-to-File stating the CRF copy has not been printed as it can be viewed on the EDC and provide that information instead of printing off many pages of a CRF (which is in EDC)?
Indresh Krishna
There is no need to print the information (pages) from the EDC. The EDC would be considered your source. However, the regulatory inspectors should be able to review such electronic CRFs. The inspector would request that someone at the site access the data and provide paper copies for any page(s) requested rather than have the regulatory inspector navigate the site's computer system. It is important to keep track of all changes made to information in the electronic records that document activities related to the conduct of the trial (audit trails). The use of audit trails or other security measures helps to ensure that only authorized additions, deletions, or alterations of information in the electronic record have occurred and allows a means to reconstruct significant details about study conduct and source data collection necessary to verify the quality and integrity of data. Computer-generated, time-stamped audit trails or other security measures can also capture information related to the creation, modification, or deletion of electronic records and may be useful to ensure compliance with the appropriate regulation.
If you are going to create a Note-To-File, a standard operating procedure should be created so that all study staff are consistent with implementing your internal processes/procedures.
We plan to broaden the inclusion criteria in one of our clinical studies. Can we re-screen and include those participants who were previously ineligible for the study?
Nitin Sabnis
The question regarding "re-screening" is influenced by specifics of the protocol. Quite often protocols do not address screening or re-screening of potential subjects. Depending on many diverse factors including the medical conditions that are being evaluated, the lab/imaging tests that are being used for this evaluation, the reasons why initial screening failed, and the nature of the study, re-screening may or may not be medically/scientifically appropriate.
This information should be put to the ethics committee (EC) that reviewed the study and approved it before implementation. The EC should have approved all consents used during the study, including those used for the subject screening process.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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