Clinical research coordination programto be held: 8/8

Clinical research coordination program to be held

The MUSC General Clinical Research Center (GCRC), with co-sponsors the College of Nursing and the Office of Research Administration, is offering an ãOverview of Clinical Research Coordination and Managementä program designed for clinical research coordinators, research nurses, data managers, and grant writers.

The program will consist of eight weekly sessions. Each weekly session will be held twice and two different days and times. Participants may select either Tuesdays from 11:30 a.m. to 1 p.m. in the Clinical Science Building (CSB) room 628 or Thursdays 3 to 4:30 p.m. in the CSB room 419. There is no charge for the program, but space is limited to 25 participants. To register, call the GCRC at 792-3256.

Session topics and dates are:

Sept. 9 and 11 Overview of the Clinical Research Process

Study Coordinating Networking

Sept. 16 and 18 Human Subjects: Rights and Protection

Special Populations
Patient Concerns

Sept. 23 and 25 MUSC IRB Policies and Procedures

Federal Regulations Relevant to Human Research
Maintaining Departmental Regulatory Files
VA IRB Approval/ R & D Committee

Sept. 30 and Oct. 2 Research Funding and Administration

Indirect Rate Calculation
Reviewing the Contract
Investigator Responsibilities

Oct. 7 and 9 Developing and Negotiating a Budget

How to Determine Real Costs
MUSC Grant Pricing/Clinical Fees
Investigational Drug Service

Oct. 14 and 16 Subject Enrollment and Data Management

Patient Eligibility
Source Documents
Adverse Event Reporting
Quality Assurance

Oct. 21 and 23 Subject Recruitment

Financial Incentives for Participation
Marketing Strategies
The Role of the Principal Investigator

Oct. 28 and 30 Preparing for Audits

Maintenance of Sponsor Study File Notebook
Pre-Study Visits
FDA Visits
Closing Out a Study
GCRC Resources and Procedures