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Q of the week

Q: Define Individual Case Safety Reports??

Get the Answer: 

Confirmatory trials
The purpose of these trials is to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate. These trials may be carried out by clinicians in the concerned therapeutic areas, having facilities appropriate to the protocol. If the drug is already approved/marketed in other countries, phase III data should generally be obtained on at least 100 patients distributed over 3-4 centres primarily to confirm the efficacy and safety of the drug, in Indian patients when used as recommended in the product monograph for the claims made.

Essential Documents and Trial Master File

  1. Define what is in-house site file and trial master file?
    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. Regulatory 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.
  2. During the trial where signed informed consent forms should be located whether it is located at Investigator / Institution or copy should be in Sponsor's/CRO file?
    We have to follow ICH-GCP. The consent forms are a confidential transaction between the investigator and the subject. Hence, the signed consent forms cannot be taken out of the institution by the sponsor/CRO for their files.



Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.