Q. What is the meaning of satellite site? If an investigator is using a satellite site, what is the procedure for approval?
● Sunil Verma
A satellite site could mean
1) Another institution where investigator has attachment or
2) Another institution which is willing to refer patient to the investigator or
3) Another investigator site willing to work under the investigator.
The procedure depends on what is the role and responsibility of the satellite site. If it is 1) or 2) an EC approval must be taken for these sites. If it is 3) an EC and regulatory approval must be taken.
Q. What if a patient has written wrong date in ICF? What should be done to resolve it?
● Sunil Verma
The investigator has to call the patient back and request him to write on the consent form that
a) there was an error while writing the date and
b) the correct date should have been (actual date of consent).
The patient should sign and date this statement with the date on which he writes this correction. This information that the patient has written wrong date should be entered in the source data.
Q. I would like to know if the regulatory guidelines state anything regarding annual progress report of the study after approval including the status of recruitment and a summary of SAEs to be submitted to EC?
● Dr Roma Basu
Please see relevant information from Indian GCP and Schedule Y.
Indian GCP 2.4.2.6. Decision Making Process
The IEC should be able to provide complete and adequate review of the research proposals submitted to them It should meet periodically at frequent intervals to review new proposals, evaluate annual progress of ongoing ones and assess final reports of all research activities involving human beings through a previously scheduled agenda, amended wherever appropriate.
Schedule Y
(ii) Ethics Committee(s) should make, at appropriate intervals, an ongoing review of the trials for which they review the protocol(s). Such a review may be based on the periodic study progress reports furnished by the investigators and/or monitoring and internal audit reports furnished by the Sponsor and/or by visiting the study sites.Approval Letter
The Institutional Ethics Committee / Independent Ethics Committee expects to be informed about the progress of the study, any SAE occurring in the course of the study, any changes in the protocol and patient information/informed consent and asks to be provided a copy of the final report.
Q. We have completed a BE study approved from DCGI for 28 patients. Now we want to increase the number of subjects to 56. Do we need DCGI approval for this amendment?
● Inder Sharma
Yes you need permission of DCGI office before you can add new subjects. All amendments need EC approval. See the recommendation from DCGI office below:
Protocol Amendments
a. Those amendments which do not require any information or permission
i) Administrative and logistic changes
ii) Minor protocol amendments and additional safety assessments in case the institutional ethical committee has already approved these changes
b. Those amendments which require to be informed but need not wait for permission
i) Additional investigator sites
ii) Amended investigators brochure, amended informed consent
c. Those amendments which require prior permission before implementation of the amendments.
i) Change of principal investigator
ii) Additional patients to be recruited
iii) Major changes in protocol with respect to study design, dose and treatment options
Q. As per our regulatory requirement we submit clinical trial dossier to DCGI. Do we need to submit the same to ICMR? What is the role of ICMR?
● Anant Jagtap
ICMR role is advisory. DCGI office needs ICMR expert advice prior to giving approval in certain situations e.g. Phase I trial of an Indian discovery or clinical trial in an area of high priority e.g. AIDS, In such a situation, the sponsor has to submit a separate application to ICMR