The National Institute of Pharmaceutical Education and Research (NIPER), Chandigarh, in association with Department of Pharmaceuticals, is organizing a five-day workshop on 'Clinical Trial Protocol Writing' from August 24 to 28, 2009.

The workshop is significant because a well-written clinical trial protocol allows researchers at multiple locations to perform the study in exactly the same way, so that their data can be integrated as though they were all working together.

The five-day workshop will have a comprehensive coverage on clinical trial protocol writing. Topics like basics of medical writing; writing SOPs; understanding of research designs; designing a study protocol; clinical trial protocol writing and clinical research report writing will be covered in the workshop by experts.

A clinical trial protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in other background and reason the trial is being conducted, but these could be provided in other documents.

The protocol contains a study plan on which the clinical trial is based. This plan is designed to safeguard the health of the participants (while limiting their financial liability) as well as answer specific research questions. The protocol describes, among other things, what types of people may participate in the trial; the schedule of tests, procedures, medications and dosages; and the length of the study.

The focus area of the workshop is to provide advancement in knowledge and skills of persons working or intending to work in clinical research. This workshop will be of special use to professionals and students associated with pharmaceutical and biotechnology industry, academic institutions, regulatory agencies, clinical research organizations and healthcare Industry.

The coordinator of the workshop, professor Pramil Tiwari said that the workshop will be of interest to the CRAs and investigators working in the field who are looking for the additional training; professionals wanting to change career within the industry/ academia to clinical research; professionals willing to get in the field of clinical research and to recently employed personnel in academia or industry requiring comprehensive training in clinical research.

Prominent personalities and experts, drawn from industry, regulatory bodies and the academia, who will deliver lectures in the workshop include Dr Vasantha Muthuswamy, former senior DDG, ICMR, New Delhi; Dr B Chakraborti, vice president, Cadila, Ahmedabad; Dr Rajesh Kher, GVK-Bio; Pralhad Dhagale, Novartis, Hyderabad; Dr R M Pandey, AIIMS, New Delhi; Dr C K Katiyar, Dabur and Dr Roma Uppal, ex- professor, PGIMER, Chandigarh.