What source documents should be created as part of the enrollment process?

ALL of the following forms should be completed during screening/enrollment:

• Clinic Screening Form (CRF-00) – completed by the physician
• Informed Consent Document (ICD) – signed & dated by both the patient and the person obtaining consent (give signed copy to the patient)
• PT Medical Info Release Form – signed by the patient (give copy to the patient)
• Patient Study Info Overview (CRF-01) – completed electronically in REDCap by RA
• Physical Exam Form (CRF-02) – Part A (range of motion) completed by physician and Part B (strength) completed by RA (either on paper or electronically)
• Baseline Questionnaire (CRF-03.1) – completed by the patient either on paper or electronically in clinic
• Surgery Report Form (CRF-05) – Operative patients only – completed by the recruiting physician either on paper or electronically within 1 week of surgery date

See H1 in Post-Enrollment Procedures for what should be done with these documents after enrollment.