Clinical Research FastrackClinical Research Professional
May. 2024RemoteICH GCP E6 R2 Informed Consent Process Comprehension and Execution of Clinical Trail Protocols FDA Regulations 21 CRF Parts 11, 50, 54, 56 Monitoring, Quality Assurance and Inspections Identification and reporting of AEs and SAEs Protecting Patients Rights and Safety Maintaining a Regulatory binder, housing essential documents including but not limited to 1572, source documents, DOA, Training Logs, ICF, SAE Forms, Financial disclosures, Site Visit Logs, Standard Operating Procedures (SOP) and Correspondences