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Old June 5th, 2014, 05:31 PM
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Default Re: Clinical Data Management Course Syllabus

The University of Pune, is a university which is located in western India, in the city of Pune.

The university was founded in 1948.

It is one of India's premier Universities.

The University of Pune has spread over a 411 acres campus.

Here I am providing you its - Clinical Research and Clinical Data Management (CRCDM) Course syllabus, below:-

• 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.

Course Structure: (100 hrs)

1. Drug Development Process

Review FDA approved process for development and approval of a drug, role of key player in drug development.

2. Informed consent process and human subject protection
Key events in history that have impacted human subject rights, review informed consent process and describe regulatory requirements.

3. GCP Regulation and Guidelines
Key concept in regulatory application such as GCP, regulation guidance and ICH guide lines. Review mandatory regulations of FDA that apply to sponsor investigator and IRB.

4. Collection of Regulatory Documents, Review and Submission
Review the regulatory documents which must be collected and maintained, discuss the role of these regulatory documents, identify strategies to ensure their accurate completion, review management of study files.

5. Adverse events (AE) and Serious adverse events (SAE)
Introduction of AE and SAE to the management that occur during the conduct of a clinical study, outline regulatory expectations for the identification, documentation and reporting of these events to the sponsor and FDA. , review process and the system involved in safety management and pharmacovigilance in both domestic and global trials.

6. The Protocol and Data Management
Review the purpose of the protocol and key factors both from CRA and site prospective, and their role in handling protocol departures, types of data collection and regulatory requirement and industry standards for collecting retrieving and analyzing subject data.

7. Site interactions

Review communication skills and concepts for interacting with site personnel; indicate key principles for establishing productive work relationship and strategies for handling site problems.

8. Managing clinical supply/ laboratories

Review CRAs role and regulatory responsibilities for managing clinical supply laboratories and test articles accountability during the conduct of a trial. Address issues of test, noncompliance and the policy to prevent or address noncompliance.

9. FDA inspections

Review the purpose of FDA inspections, preparation for an FDA inspection, activity during an inspection, and outcome of an inspection activity following FDA inspections

10. Source Document Verification

A brief review of basic data management concepts, discuss actual process of source documentation verification, addressing CRAs responsibilities, strategies and helpful hints for attacking data and problem resolution.

11. Training Orientation

Review role of monitor trainee including site objectives, pre-approval requirements for site visits, site visit planning, site visit expenses and expense forms, site visits SOPs and documentation and sign of for training to perform independent site visits.

12. Interim visits

Review the activities that take place during interim site visits and discuss the methodology for solving the most common problem that occur at investigative sites.

13. Site close out audit and inspections

Familarize new CRAs with activities that occur at the end of a trial and their responsibilities for completion of these activities.
Assignments : (100 hrs)
• Discuss legal and ethical issues to be considered in subject selections.
• Issue of women and minority group in clinical research
• What factors will you keep in mind in selecting the site?

Project: (175 hrs)

CDM 301: Bio-statistics using SAS techniques
(375 hrs. 75 hrs teaching + 100 hrs assignments+ 200 hrs Project)
This program has been designed to provide advance Bio-statistics training and its application with SAS for a diverse range of students. It is primarily aimed at those wishing to become trained professionals and wanting an in-depth theoretical and practical statistical knowledge. From this course candidates will
- Be able to demonstrate a broad understanding of the value and basic principles of Bio-statistics methods in health and medical/clinical research.
- Develop the practical and technical skills with SAS software for better interpretation of the data from clinical studies.

For complete syllabus, download the attachment given below:-

Contact address:
University Of Pune
Ganeshkhind, Pune, Maharashtra 411007 ‎
020 2560 1099 ‎


Attached Files Available for Download
File Type: pdf University of Pune (CRCDM syllabus).pdf (112.6 KB, 39 views)
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