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What are the regulatory expectations when a sponsor plans to have direct remote access to clinical trial data?
Dr Sanjay Desai
Direct remote access by the sponsor team implies any access from an access point that is not under the control and supervision of the investigator/institution. This could include o identifiable personal and health data of participants. Hence, the informed consent documentation should clearly explain to the participants that in addition to the investigator/site team, certain authorised personnel of the trial sponsor - monitor, auditor as well as regulatory inspectors may require direct remote access to their confidential health documents.
The protocol should include:
• a description of the arrangements to comply with the applicable rules on the protection of personal data; organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure, dissemination, alteration or loss of information and personal data processed.
• a description of measures that will be implemented to ensure confidentiality of records and personal data of trial participants.
• a description of measures that will be implemented in case of data security breach to mitigate the possible adverse effects.
The technology used for such direct remote access should comply with requirements of ensuring privacy, confidentiality and data integrity.
I have signed consent forms in the past, that I don’t have copies of, how do I withdraw consent?
Ramesh Kale
As per Good Clinical Practice (GCP), you have rights to decide whether you wish to withdraw from a clinical trial.
ICH GCP
4.3.4. Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the subject's rights.
4.8.10. m) That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.
You can withdraw consent in writing, verbally, or by not further participating in the study. If you have any contact information of the hospital/clinic for the trials in which you have participated, you can contact them and let them know that you are withdrawing your consent. If you do not have records and cannot contact them, you can stop participating in the study.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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