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One clinical trial participant withdrew informed consent. However, his/her blood sample was collected prior to withdrawal, but was not yet analyzed. Can the sponsor analyze previously collected sample?
Dr Shalini Nair
If a clinical trial participant withdraws his/her consent to continue participating in a clinical trial, then all study procedures should be stopped, including analyses of biospecimens. There should be no further data accrued once an individual makes the decision to withdraw his/her consent. However, a withdrawal of consent does not extend to the data already obtained during the time the subject was enrolled; i.e., prior to the withdrawal.
Regulatory authorities would expect that all data collected up to the point of withdrawal must be maintained in the database and included in subsequent analyses, as appropriate. Hence, the sponsor can analyze sample collected prior to withdrawal of consent.
What are the responsibilities of an investigator regarding collection of data after a subject withdraws from a clinical trial?
Dr Sunitha Ramkrishnan
According to FDA regulations, when a subject withdraws from a study, the data collected on the subject to the point of withdrawal remains part of the study database and may not be removed.
- An investigator may ask a subject who is withdrawing whether the subject wishes to provide continued follow-up and further data collection after their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the subject would distinguish between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the subject's information.
- If a subject withdraws from the interventional portion of the study, but agrees to continued follow-up of associated clinical outcome information as described in the previous bullet, the investigator must obtain the subject's informed consent for this limited participation in the study (assuming such a situation was not described in the original informed consent form). In accordance with FDA regulations, IRB approval of informed consent documents would be required.
- If a subject withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the investigator must not access for purposes related to the study the subject's medical record or other confidential records requiring the subject's consent. However, an investigator may review study data related to the subject collected prior to the subject's withdrawal from the study, and may consult public records, such as those establishing survival status.
The investigator site and the Ethics Committee should have appropriate standard operating procedures to address the diverse options after a subject withdraws consent.
How does a site document a copy as "certified"?
Abhay Deshpande
Certified copy means a copy of original information that has been verified, as indicated by dated signature, as an exact copy having all the same attributes and information as the original. Use of a certified copy generally assumes that the original records are copied to a different media (e.g., electronic records such as a pdf file) for archiving purposes and the originals are destroyed. If it is decided to have a certified copy substitute for the original, it is recommended that you develop an SOP describing how such copies would be made verified and documented. The person who certifies the copy as an accurate and complete representation of the original, having all of the same attributes and information should be the same person who actually made the copy from the original. Certification should be accomplished by having the person who makes the copy, sign or initial and date of the copy to indicate it meets the requirements of a certified copy as described above. This should be described in the SOP and can be accomplished by initialling and dating each copy or by initialling and dating a document certifying copies in bulk. Whichever method is used the SOP should describe the procedure.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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