BII Institute had planned a 4 day educational visit to NIMR from 20th Jan’09 to 24th Jan’09, at Civil Lines. We got this golden opportunity to visit NIMR because of Dr.Kumud Sarin and Dr. Neena Valecha.
The visit to NIMR was very well planned. It was a very good opportunity for BII students to communicate with well experienced staff working under Dr. Neena Valecha. We are also thankful to Mrs. Beena Srivastava who took care of BII students, under the guidance of Dr. Neena and Mrs. Beena we got to know about the minute details of protocols, CRF’s and ethics committee.
We started our session by discussing phases of Clinical trials. We also discussed on other aspect of Clinical Trials. Mrs Beena showed us the protocols, different versions of protocols that involved multi as well as single centric studies. All the queries regarding the protocol were resolved by Mrs. Beena. They also showed us how amendments were made in protocols. We were made to read protocols and told to review the minute details about the protocol. They also discussed about the ICD. Mrs. Beena shared her experiences of malarial research. She also explained about the importance of GCP during a Clinical Trial.
In the next session, our queries on clinical research were resolved by Mrs. Beena. On the second day we started discussion on ethics committee and regulatory body. She discussed with us about the procedures involved in meeting conducted by ethics committee, e.g.: the minutes, the agenda, the proposals, EC approval letters, protocol deviation / violation, SAE’s report. She also showed us the IND application and the requirements of document related to approval of protocol along with Investigators Brochure, CRF’s, DCF, CRF books.
Students who have participated in the visit are Meeta, Anika, Divya, Nidhi, Shilpi, Rakhi, Imran, Aarti, Prashant, Preeti.
Overall, it was a very refreshing, gainful experience in terms of education and practical aspects. It builds in us the confidence that we can achieve heights in the filed of Clinical Research.
We would like to thank Dr.Kumud Sarin, Dr. Neena Valecha and Mrs. Beena Srivastava for allowing us to visit NIMR and providing us with this opportunity. We are also thankful to them for sharing their valuable time and experiences.
From: BII Students for the Advance Program in Clinical Trial, Research & Data Management
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