Download the Training Template (DOC).
Topic: Human Subjects Research
Study Termination Visit
Download the Study Termination Visit Template (DOC).
Sponsor CRO Audit
Download the Sponsor CRO Audit Template (DOC).
Reporting Unanticipated Problems, SAEs, and Adverse Drug/Device Events
Download the Reporting UPs, SAEs, and Adverse Drug/Device Events Template (DOC).
Preparation and Handling of Laboratory Samples
Download the Preparation and Handling of Laboratory Samples Template (DOC).
Patient Recruitment
Download the Patient Recruitment Template (DOC).
Management of Source Documents and Case Report Forms
Download the Management of Source Documents and Case Report Forms Template (DOC).
IRB Approval
Download the IRB Approval Template (DOC).
Investigational Product Management
Download the Investigational Product Management Template (DOC).
Informed Consent Process and Documentation
The ethical conduct of clinical investigations is based upon a process by which a participant voluntarily confirms her willingness to participate in a particular trial.