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CRC 270 - Research Management for Sponsors and CRO’s

1. Identify professional and behavioral skills required of the Clinical Research Associate (Monitor).
2. Discuss the relationship between Sponsor, CRO, and the clinical research site.
3. Develop a plan for data quality assurance.
4. Communicate effectively to CRC during the Site Initiation Visit, Interim Monitoring Visit, and Close-Out Visit
5. Evaluate research data for completeness, compliance, and accuracy
6. Define on-site, centralized, remote, and risk-based monitoring visits

1. Professional and Behavioral Skills of the Clinical Research Associate
2. Processes Involved in the Development of a Research Study Budget
   1. Estimating study costs and a site budget
   2. Analyzing the budget components for a specified clinical trial relative to cost effectiveness
   3. Assisting in the calculations of an overall research project budget, including personnel, costs, overhead, and profit margin
3. Planning a Clinical Research Trial from the Perspective of a Clinical Research Associate   
   1. Types of CROs
   2. Components of a typical bid, proposal, and contract with CRO
   3. Role and responsibility of a Clinical Research Associate in the development of a research contract with a CRO
   4. Delegation of responsibilities and outsourcing to a CRO and considerations for this relationship
   5. Communication between project team members and clinical trial management
   6. Problems commonly occurring between CROs and clients (Sponsors)
   7. Design of study Case Report Forms  (CRF)
   8. Implementation of start-up activities including:
      1. Site recruitment and selection
      2. Essential document collection and approval
      3. Investigational product shipment
   9. Set timelines in a well-coordinated research project
4. Planning, Preparation, and Conduction of Evaluation, Initiation, Periodic Monitoring, and Termination Study Site Visits                                                                                               
   1. Development and critical elements of a monitoring plan for a typical study
   2. Various study visits and development of an agenda for each type
   3. Challenges experienced by a monitor while traveling on site visits
   4. Responsibilities of the monitor and the site personnel for each type of visit
   5. Components needed in a summary report for each type of site visit
   6. The roles and responsibilities of the site coordinator and the monitor relative to subject data documentation and verification
   7. Source documentation
   8. Case report forms
   9. Process for reporting adverse events and serious adverse experiences
   10. Development of a database for each study subject visit
   11. Development of a monitoring report providing feedback to the investigator and site coordinator
5. Effective Management of Research Sites
   1. Basic procedures and tasks needed to implement a clinical study at a given study site
   2. Responsibilities and roles of key personnel participating in the management of a research site
   3. Qualifications for the investigator, study coordinator, and monitor in conducting research in Phase I, Phase II, and Phase III clinical trials
   4. Regulatory documents required of a research site
   5. Development of an investigator questionnaire/survey for recruitment purposes
   6. Development of a study subject recruitment plan
   7. Development of source documentation templates
   8. Development of sample procedures for the management of a research site, including recruiting, budgeting, and timelines
   9. Databases, logs, and files utilized in the maintenance of a study site
   10. Determination of the quality performance of a research site
   11. Different roles of a monitor and the site in the preparation, maintenance, and submission of required reports
6. Evaluation of Research Data for Completeness, Compliance, and Accuracy
   1. Source document verification on typical study cases
   2. Data collection forms for completion and accuracy
   3. Essential document collection during the course of a clinical trial
   4. Assessment of pertinent data for a specified research publication
   5. Review research data for subject safety
7. Preparation for and Conduct of the Sponsor Quality Assurance (QA) Audit
   1. Differences between a monitoring visit and a sponsor audit
   2. Purpose of a QA audit and typical findings
   3. Preparation for a QA audit
   4. Assessment of outcomes of audits
   5. Examples of instances of scientific misconduct

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