The HSRC was established in 1997 with the following
mandate:
- To set highest standard of clinical research as an integral
part of clinical patients service
- To formulate institutional policies for clinical trials
and co-ordinate activities o f Clinical Research Secretariat
for quality control of data and analysis.
- To institute guidelines and monitor Intramural Hospital
Research Projects.
- To review other research projects submitted for sanction.
- To plan for closer interaction between the clinics and
laboratories in TMH and CRI with special Reference to ACTREC.
- To implement and supervise the recommendations of the
Scientific Advisory Committee.
- 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:
- Investigator initiated projects or trials, soliciting
funding from national funding agencies;
- Investigator initiated projects or trials, soliciting
funding from international funding agencies;
- Investigator initiated projects but where no specific
funding is required;
- Multicentric academic trials with national collaborators;
- Multicentric academic trials with international collaborators;
- Pharmaceutical company sponsored trials
- Intramural projects: collaborative projects between TMH
and ACTREC CRI with specifically earmarked funding from
TMC.
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