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The HSRC was established in 1997 with the following mandate:

  1. To set highest standard of clinical research as an integral part of clinical patients service
  2. To formulate institutional policies for clinical trials and co-ordinate activities o f Clinical Research Secretariat for quality control of data and analysis.
  3. To institute guidelines and monitor Intramural Hospital Research Projects.
  4. To review other research projects submitted for sanction.
  5. To plan for closer interaction between the clinics and laboratories in TMH and CRI with special Reference to ACTREC.
  6. To implement and supervise the recommendations of the Scientific Advisory Committee.
  7. To maintain our leadership as a national standard of reference in all Departments.

The committee comprises of nearly 25 members of whom 4 or 5 are scientists from ACTREC CRI while others are drawn from the staff of TMH. More recently a pharmacologist has been included on the Committee to advise on matters relating pharmacodynamics of new compounds. The committee meets on the second Tuesday of every month.

All research projects/clinical trials involving human subjects are processed through the HSRC. The projects are sent to at least 2 referees who can either be internal or external depending on the available expertise specific to project. Once the referees' comments have been received the projects/trials is included in the agenda for discussion at the nest HSRC meeting. The principle investigator is requested to make a brief presentation of project/trial. A discussion is the held on the various aspects of the study including novelty of idea, clarity of hypothesis, research design, statements of end points, sample size, clinical relevance, adequacy of literature review time frame, adequacy of expertise of Investigators, etc. The investigator is asked to respond to the referee`s comments. The project is then scored by each investigator on a standard proforma with a scoring system. The average score is calculated the project approved, rejected or sent for revision.

The projects dealt with by the HSRC are:

  1. Investigator initiated projects or trials, soliciting funding from national funding agencies;
  2. Investigator initiated projects or trials, soliciting funding from international funding agencies;
  3. Investigator initiated projects but where no specific funding is required;
  4. Multicentric academic trials with national collaborators;
  5. Multicentric academic trials with international collaborators;
  6. Pharmaceutical company sponsored trials
  7. Intramural projects: collaborative projects between TMH and ACTREC CRI with specifically earmarked funding from TMC.
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Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai - 400 012 India. Tel. +91-22- 24177000, 24146750 - 55 Fax: +91-22-24146937
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