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Can an investigational site or a CRO destroy/remove any documents with errors from their site or trial master files if a revised, corrected version is issued?
Dr Sunita Mishra
Regulatory authorities expect that all study documents are available during an inspection. They do not recommend removing/destroying study documents from study files. When an error is discovered, there should be an appropriate audit trail to explain what transpired. If the sponsor should have a detailed SOP to manage study documents (including document corrections) and create adequate audit trails to address errors in study documents and/or to identify duplicate documents.
We have been approached by an investigator site to oversee an ongoing clinical trial at the site because the EC of the site is non-functional. Can we accept such transfer of studies?
Dr Priyanka Subrahmanyam
Your EC can take over responsibility for clinical trial at another site in compliance with provisions of New Drugs & Clinical Trials Rules 2019.
As per New Drugs & Clinical Trials Rules 2019 (i) clinical trial at each site shall be initiated after approval of the clinical trial protocol and other related documents by the Ethics Committee of that site, registered with the Central Licencing Authority under rule 8, OR
(ii) where a clinical trial site does not have its own Ethics Committee, clinical trial at that site may be initiated after obtaining approval of the protocol from the Ethics Committee of another trial site; or an independent Ethics Committee for clinical trial constituted in accordance with the provisions of Rule 7:
• Provided that the approving Ethics Committee for clinical trial shall in such case be responsible for the study at the trial site or the centre, as the case may be:
• Provided further that the approving Ethics Committee and the clinical trial site or the bioavailability and bioequivalence centre, as the case may be, shall be located within the same city or within a radius of 50 kms of the clinical trial site.
Your EC should have an SOP for overseeing such studies from another site. The EC should review all important documents e.g., regulatory approval, EC approval, Informed Consent Forms, Investigator’s Brochure, Protocol, safety information, EC monitoring findings before accepting the study. The informed consent should be amended. The participants should be aware of the change in overseeing EC.
Is it mandatory to provide patient data in Clinical Trial Registry of India (CTRI)?
Bharat Koppikar
Internationally, transparency in clinical trial reporting requires display of clinical trial results in a public registry. Availability of results database in a registry: (1) provides a public record of basic study results in a standardized format for researchers, journal editors, IRBs, ethicists; (2) promotes the fulfilment of ethical obligations to participants and the overall contribution of research results to medical knowledge for patients, the general public, the research community; (3) reduces publication and outcome reporting biases for users of the medical literature; and (4) facilitates systematic reviews and other analyses of the research literature for researchers, policymakers. However, at present, it is not mandatory to provide results of clinical trial in Clinical Trial Registry of India.
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