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Regarding use of source data template there is no regulation

Dr Arun Bhatt
Thursday, September 3, 2015, 08:00 Hrs  [IST]

For an epidemiological observational study, pregnant mothers need to be recruited with a very close delivery date. In this case, is it permissible to conduct the consenting process by the field workers at the subject’s house?

Monali Babre

ICMR 2006 guidance recommends that when individuals are to be included as participants of any epidemiological studies, the purpose and general objectives of the study has to be explained to them keeping in mind their level of understanding. In spite of obtaining informed individual consent, it is quite likely that the participants/patients may not be fully aware of their rights.

In this context, the role of investigator is crucial and she/he should remain vigilant and conscious of her/his obligations towards the participants/patients, all through the course of the studies.

According to Field Training Guide for Human Subjects Research Ethics (PLoS Med. 2010 Oct; 7(10): e1000349) a field worker can conduct consenting process. However, this requires thorough training in diverse areas. See the excerpt below:

The consenting process should always be carried out by a responsible cadre of workers articulate in the local language and culture. In some research settings, workers authorized to administer informed consent are the same individuals who collect all the data, whereas in other settings consent is only within the purview of supervisor-level staff.

Approaching subjects to seek informed consent or collect data in community research usually involves contact not only with the prospective subject but also with senior decision makers in the family. The very event of a home visit by a field worker has the potential to breach a subject's confidentiality by exposing private circumstances to the neighborhood, as when a field worker tests a subject for pregnancy and brings antenatal supplements on subsequent visits. Field workers in community settings are often pressed by local government officials, opinion leaders, family heads, or NGO workers to divulge information about study subjects, as in studies of sexually transmitted conditions or other sensitive matters. Field workers need to be trained to manage these complex social situations so as to protect subjects' privacy and the confidentiality of personal information.

By contrast, field workers in low-resource settings need easily accessible, pared-down instruction on the essentials of protecting human subjects, including how to obtain consent in a respectful and diligent manner, how to protect the confidentiality of the data they are collecting, and a few other key ethical concepts. In addition, they need practical support to perform their jobs well, such as guidance on specific behaviors to direct their interaction with human subjects.

As an agent representing study investigators and the institutions charged with ethical oversight of the research protocol, the data collector bears two weighty responsibilities: to act respectfully and otherwise appropriately toward each study participant with whom he or she has contact for research purposes; and to safeguard the confidentiality and integrity of the data that he or she collects.

This includes detailed instruction on specific behaviours that promote basic ethical principles: for example, paying attention to body language when seeking informed consent or recording interview responses, and safeguarding data collection sheets to protect the confidentiality of personal information.

Can Certificate of Analysis (CoA) be shared with clinical investigational site?
Bhavik Patel

The purpose of CoA is to document purity, identity and strength of IP. This is essentially a QA certificate of analysis of various parameters of IP to comply with GMP requirements. CoA does not have any specific information to guide the investigator in conduct of the trial. The product information including dosing is contained in IB and protocol. Hence, keeping a CoA copy in site file is not mandatory.

Can we use source template to record source data in clinical trial? Is there any regulatory guidance?
Bhavik Patel

There are no regulations regarding use of source data template. However, the regulatory agencies expect that the
  1. Source data should be accurate, legible, contemporaneous, original, attributable, complete and consistent and
  2. An identification list of where source data is documented should be available. (This will help monitors, auditors and inspectors in their work.) and
  3. The record should contain information relating to the study subject, visit records, test records, medical history, diagnoses, treatments etc.
The regulators expect a documentation of investigator's agreement, prior to study start, on how source data would be captured and an SOP for source documentation practices.

During AV recording of ICF process, can we just capture AV start and stop time and ICF presentation time given to patient, instead of the whole process?
Rajesh More

The regulatory requirement for AV recording is:

An audio video recording of the informed consent process of individual subject, including the procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.

Hence, AV recording includes the whole process including explanation of essential elements (as per Sch Y) and signing of the ICF.

Dr Arun Bhatt is currently, president, ClinInvent, Research Pvt Ltd,
Mumbai. Readers can send their queries at: arunbhatt@clininvent.com


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