Q. What is the difference between in-house site file and trial master file?
● Tushar Mhetre

Trial master file (TMF) is a file that contains all the essential documents relating to a clinical trial, before the trial commences, during trial conduct and after the completion of trial.

The clinical trial related essential documents should be filed in the files for easy retrieval of data/information and audit/inspection. Based on the location and contents, it can be divided into 3 files:

● In-house study file: The In-house study file consists of essential documents, which are central in nature, received from sponsor/regulatory authorities relatedness investigational product/approval/process, original contracts with sponsor and third party (if exists) e.g. DCGI approvals, GMP certificates, insurance, indemnification etc. This file is kept at CRO/sponsor office.

● Investigator site file (ISF): This file consists of essential documents related to that specific investigator site. This is kept at the investigator site.

● In-house site file: It consists of essential documents related to all the investigator sites. This is kept at the sponsor/CRO office. This file is essentially an in-house replica of the Investigator Site File maintained at the site.

Q. I plan to conduct a device trial in my clinic. This is an observational study with no invasive procedures. Do I need EC approval? If yes, how can I get EC approval for this study?
● Dr Shantanu Kumar

ICMR guidelines (2006) suggest the need for EC approval for the epidemiology studies. Hence it is desirable to obtain EC approval. You can approach Independent Ethics Committees in Mumbai, Ahmedabad, Delhi or Bangalore.

Q. I plan to import a medical device from USA. The US laws state that for a medical device (which has not yet received FDA 510 K approval) to be exported, the exporter should produce records demonstrating that the product does not conflict with the laws of the importing country. What are the laws in India for medical devices?
● Dr Shantanu Kumar

You will need approval from the DCGI office in New Delhi. Central Drugs Standard Control Organisation (CDSCO) website (www.cdsco.nic.in) mention the guidelines for import and manufacture of devices (Mar 2006).


Q. What is the exact condition of regulatory inspection in India?
● Prashant Srivastava

DCGI office has organized workshops to train the inspectors. DCGI office has not conducted any inspections in India. FDA has conducted inspections at 8 investigator sites.

Q. For one of our clinical trials, the patients are required to use digital diaries to enter their pain level. We need to import these diaries. In this scenario, do we need to get approval from DCGI?
● Lakshmanan

You need to submit the screen shots of the electronic diaries (including translations) to DCGI and EC for approval. For import of diaries - No DCGI approval is required - a custom clearance is fine (commercial shipment). An additional requirement for custom clearance of the diaries would be to provide a technical write up and product catalogue.

Q.What is the role of the chairperson EC? Who signs the EC approval letters chairperson or member secretary?
● Lalitha Sreevatsa

Role of chairperson:

● The chairperson presides over all the EC meetings.

● The chairperson is responsible for conducting all committee meetings and leads all the discussions pertinent to the review of research proposals.

● If the chairperson cannot attend a meeting, the chairperson will nominate a committee member as the acting chairperson. The acting chairperson will have all the powers of the chairperson for that meeting only.

● The chairperson is responsible for assessing the training needs of the EC members and ensuring that they are trained.

● Expedited review: Chairperson or designated member of the EC may do expedited review.

The EC approval letters are signed by the member secretary.