The GCP SBR Advanced Refresher course reinforces the importance of concepts covered in the basic level GCP – Social and Behavioral Research Best Practices for Clinical Research course. This refresher course goes in-depth on more advanced GCP concepts (for example, specific issues like monitoring, audits, inspections, and data and safety monitoring), expands upon the breadth of the investigator’s responsibilities, and explores topics relevant to social sciences research and behavioral trials not traditionally covered in GCP courses (such as when social behavioral research could be considered a clinical trial, social media use in research, and deception in informed consent).
This course meets the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors when the following modules are completed:
- Overview of ICH E6 GCP for Behavioral Interventions and Social Science Research
- Investigator’s Role and Responsibilities in Behavioral Interventions and Social Science Research
- Informed Consent in Behavioral Interventions and Social Science Research
- Monitoring, Audits, Inspections, and Data and Safety Monitoring of Behavioral Interventions and Social Science Research
- In-Depth Review of ICH E6 and TransCelerate Minimum Requirements
The National Institutes of Health (NIH)* also requires completion of GCP training that demonstrates that individuals have attained fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials involving human research participants.
* NIH in fulfillment of their GCP training policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) states that NIH-funded investigators and staff should be trained in GCP. The NIH does not endorse any specific training programs. CITI Program offers several GCP courses that are considered acceptable by many leading organizations to meet their training needs per NIH policy released on 16 September 2016.
Language Availability: English
Suggested Audiences: Social and behavioral investigators and staff
Organizational Subscription Price: Included with Good Clinical Practice series, available as part of an organizational subscription package or for $1,000 per year/per site for government and non-profit organizations; $1,200 per year/per site for for-profit organizations
Independent Learner Price: $129 per person
