Q. In a retrospective study, if the sponsor or investigator wants to use the medical records of the patient database of his centre, is it mandatory to obtain the ethical committee (EC) approval and the consent of that particular patient?
● S Gurunath
The sponsor can not use the retrospective data directly. He has to obtain the data through the investigator. If the patients are part of the investigator's database, he can use them after the institutional EC have given permission.
Generally agreed upon criteria for allowing retrospective record review without patient consent
● When record review would not pose more than minimal risks to subjects
● When research could not practicably carried out if consent were to be required
● When research will not adversely affect the rights or welfare of subjects.
Q. As per Indian regulations, when is the start date of safety reporting local and overseas SAEs for clinical trials. Is it after regulatory and EC approval? After site initiation visit? After first patient first visit?
● Pratyush
There is no clear Indian regulation. Logically, overseas SAEs must be reported as soon as you receive regulatory approval. The local SAEs for the trial can only be reported after the first patient is screened.
Q. Do we need to have a sponsor's approval page in the protocol?
● Dr Anand Jain
Yes. Usually the signature page comes after the title page and contains space for all signatures
● Investigator
● Sponsor responsible person usually medical director / head clinical research
● Sponsor's statistician (if applicable)
Q.Please let me know whether herbal products (made in India) for local application (such as ointments, nose or eye drops, etc) are exempt from phase I trials here? Can such products be registered by getting straight in to a phase II trial and by-passing first in man altogether?
● Dr Roopa Basrur
The Indian GCP guidelines recommend as follows:
For the herbal remedies and medicinal plants that are to be clinically evaluated for use in the Allopathic System and which may later be used in allopathic hospitals, the procedures laid down by the office of the DCG (I) for allopathic drugs should be followed.
It may not be necessary to undertake phase I studies. However, it needs to be emphasized that since the substance to be tested is already in used in Indian Systems of Medicine or has been described in their texts, the need for testing its toxicity in animals has been considerably reduced. Neither would any toxicity study be needed for phase II trial unless there are reports suggesting toxicity or when the herbal preparation is to be used for more than 3 months. It should be necessary to undertake 4-6 weeks toxicity study in 2 species of animals in the circumstances pointed out in the preceding sentence or when a larger multicentric phase III trial is subsequently planned based on results of phase II study
The regulatory situation re: clinical trials of herbals is unclear as traditionally, any company can market a herbal, if it is known / cited in any of the approved ayurvedic texts, after obtaining a licence from state FDA. Besides, DCGI office usually does not consider herbal drug clinical trials. Dept of Ayush is involved in opining on such issues.
Q.Can a sponsor attend IEC meet if IEC request sponsor to do so particularly to give explanation on queries raised by IEC on preclinical data?
● Dr Virupaksh Mahaparale
Yes. As per Indian GCP, if necessary, the applicant/investigator may be invited to present the protocol or offer clarifications in the meeting. However, the sponsor should not be present when IEC discusses the protocol and is voting for a decision.
Q.What to do if a site person takes informed consent before signing Signature and delegation log?
● Dr Virupaksh Mahaparale
If consent is taken before the authorized person signs the log, this should be documented as a file note in site file and in source notes. The relevant signature log should be completed with current date.