Writing and Maintaining SOPs

Document Control Management

Regulatory Documentation

Source Documentation

Source Documentation Checklist

CRF Completion

Electronic Records

Investigator's Site File

Printing and Certifying Medical Records

IRB/IEC Submissions

AE Reporting

Informed Consent Process

Eligibility and Enrollment

Subject Recruitment

Training Clinical Research Personnel

Responsibilities of The Research Team

Study feasibility

Protocol Compliance

Privacy Confidentiality

Conflicts of Interest

Communication Practices

Clinical Study Conduct

Protecting Confidential Information

Subject Payment

Study Visits

Site Selection Visit

Site Initiation Visit

Site Monitoring Visit

Quality Control

Site Close Out Visit

FDA Audits

CAPA

Temperature Monitoring

Randomization Blinding

IP Accountability

Injected Meds Preparation

Equipment Maintenance and Calibration

Specimen Collection Management

Venipuncture

Biosafety guidelines during COVID-19 Health Emergency