Standard Operating Procedure for Electronic Systems and eCRFs Purpose This SOP outlines the procedures for the use of electronic systems and electronic case report forms (eCRFs) in clinical trials and…
Standard Operating Procedure for Data Privacy and Confidentiality Purpose This SOP outlines the procedures for ensuring data privacy and confidentiality in clinical trials and clinical studies. The goal is to…
Standard Operating Procedure for Electronic System Validation and Qualification Purpose This SOP outlines the procedures for the validation and qualification of electronic systems used in clinical trials and clinical studies.…
Standard Operating Procedure for Sponsor and CRO Communication Purpose This SOP outlines the procedures for communication with sponsors and Contract Research Organizations (CROs) in clinical trials and clinical studies. The…
Standard Operating Procedure for Managing Complaints and Feedback Purpose This SOP outlines the procedures for handling complaints and feedback in clinical trials and clinical studies. The goal is to ensure…
Standard Operating Procedure for Placebo and Comparator Product Management Purpose This SOP outlines the procedures for the use of placebos and comparator products in clinical trials and clinical studies. The…
Standard Operating Procedure for Safety Reporting to Ethics Committees and Institutional Review Boards Purpose This SOP outlines the procedures for safety reporting to Ethics Committees and Institutional Review Boards (IRBs)…
Standard Operating Procedure for Archiving and Long-Term Record Storage Purpose This SOP outlines the procedures for archiving and long-term storage of records in clinical trials and clinical studies. The goal…
Standard Operating Procedure for Quality Risk Assessment and Mitigation Purpose This SOP outlines the procedures for quality risk management in clinical trials and clinical studies. The goal is to proactively…
Standard Operating Procedure for Managing External Laboratory and Diagnostic Services Purpose This SOP outlines the procedures for managing external laboratory and diagnostic services in clinical trials and clinical studies. The…