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No regulatory requirement prescribed for trial of non-notified IVDs

Thursday, December 03, 2015, 08:00 Hrs  [IST]

For double blind studies is it necessary that QA auditors and sponsor monitors should also remain blinded? Can audit of dispensing, dosing and other relevant activity be audited by the same auditor?  
Rushikesh Kansara

As per ICH E9 guidance, a double-blind trial is one in which neither the subject nor any of the investigator or sponsor staff who are involved in the treatment or clinical evaluation of the subjects are aware of the treatment received. This includes anyone determining subject eligibility, evaluating endpoints, or assessing compliance with the protocol. Hence, it is necessary for QA auditors and sponsor monitors to remain blinded.

One option is to have two different monitors. Their roles would be as follows:
• Blinded Monitor: A monitor designated to perform site monitoring activities except for pharmacy, drug accountability, and reconciliation of the blinded investigational products.
• Unblinded Monitor: A monitor designated to perform the site monitoring activities for pharmacy, drug accountability, and reconciliation of the blinded investigational products.
The same option can be used for audit by having two auditors - blinded and unblinded.

In patient based PK studies conducted in hospitals, is there any conflict of interest that investigator can raise for in-process audit by QA?
Rushikesh Kansara

If a CRO staff is involved in managing PK study, and the audit is conducted by the same CRO, there will be conflict of interest for the auditor. The auditor would have a conflict of conducting an audit for a study which is generating revenue for his/her CRO. See the definition below.
Conflict of interest is a situation in which an internal auditor, who is in a position of trust, has a competing professional or personal interest. Such competing interests can make it difficult to fulfill his or her duties impartially. A conflict of interest exists even if no unethical or improper act results. A conflict of interest can create an appearance of impropriety that can undermine confidence in the internal auditor, the internal audit activity, and the profession. A conflict of interest could impair an individual’s ability to perform his or her duties and responsibilities objectively.

If we have a patient in a clinical trial that is illiterate and there are self- administered questionnaires expected, how is this process handled in India?
Sneha Gupta

If the patient is illiterate, he/she cannot take part in a trial which requires self administered questionnaire. However, if the questionnaire is pictorial and simple for illiterate patients to understand, then all the patients can take part. If someone reads the questions to subjects and records exactly what the patient said into the questionnaire, it is considered interviewing not self-administered questionnaire.

We wish to conduct a comparative diagnostic BE Study of PPD-Tuberculin in different patient groups. Should we apply for permission under drugs since PPD is identified as biological diagnostic antigen in the Act?
Dr Sanjeev Gupta

PPD-Tuberculin would be considered a non-notified in-vitro diagnostic device (IVD) for diagnostic purpose. There are no regulatory requirements prescribed for clinical trial of such non-notified IVDs.
If PPD is identified as drug, then you need to consider whether it is under category of new drug as per 122E i. e. is there any change in indication/dose/ formulation or is it within 4 years window. Only clinical trials of new drugs require approval from DCGI.

You can apply for DCGI permission. But it is likely that DCGI office will take time to review the application and obtain opinion of Scientific Expert Committee before issuing an NOC. The process can take 6 months or longer. One option is - DCGI office has announced that an applicant can consult DCGI office before applying for clinical trial permission. You can explore this option.


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Bharath Dec 17, 2015 4:18 PM
Dear Sir,

Kindly clarify "Is DCGI approval required to transfer the BE study from one CRO to another CRO? or only Notification to DCGI is sufficient to initiate the study?"
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