The syllabus for Clinical Research and Clinical Data Management (CRCDM) Course as offered by Pune University is as follows:

CRM 301
Medical writing and scientific publications:
(375 hrs: 75 hrs teaching + 100 hrs assignments +200 hrs project)

Course structure: (75 hrs)
• Basic introduction to medical writing terminology
• Overview of drug development, regulation and sequence, clinical background and drug discovery
• Pharmacological testing and pre-clinical research
• Filing of INDA, clinical trials protocols, phases of clinical research, filing of NDA
• Documents of drug submission and for medical community
• Writing of research reports, clinical trial reports
• Supportive documents for investigational brochure for clinical research, publication for medical community, authorship and ethical issues
• Manuscript preparation, material for professional meetings, poster and slide presentation in seminars and conferences.
• Promotion material for marketing keeping in view the legal and ethical issues.
• Literature search, discuss appropriate view of theory and conceptual frame work in research
• Selection of methods used in design, sample size, and data collection procedures that are appropriate, specific research questions.
• Purpose of literature reviews, reviews familiarities with library services and on-line databases.

Assignments some examples: (100 hrs)
• Critical evaluation of a published research article
• Conduct a literature review and summaries the findings.
• Preparation of a research proposal.
• Critical evaluation of research reports
• Conduct literature research on an assigned topic.
• Preparation of promotional material for marketing keeping in view the legal and ethical issues.
Project: (200 hrs)
All given assignments will be related to the areas of clinical research and trials.

Attached Files

Pune University CRCDM.pdf (112.6 KB, 147 views)