Quality Assurance

ACTG-CRO has comprehensive and detailed SOPs (Standard Operating Procedures) to guide and train all the staff, to ensure operations to be carried out in compliance with ICH/GCP & regulations and to fulfill sponsor requests and requirements.

STANDARD OPERATING PROCEDURES FOR CLINICAL TRIALS​
  • SOP of Agreements, Approvals and Contracts

  • SOP of Data Collection

  • SOP of Data Management

  • SOP of Developing Protocol

  • SOP of Disseminating findings

  • SOP of Enrolling and retaining participants, managing visits

  • SOP of Archiving Essential Documents

  • SOP of Archiving trial data

  • SOP of Essential documents for conduct of Clinical Trial Checklist

  • SOP of Investigator Brochure

  • SOP of  Investigator Site file set up and maintenance

  • SOP of Trial Master File contents

  • SOP of Ethics and Human Subjects Protection

  • SOP of Finance Management

  • SOP of General Logs and Trackers

  • SOP of Handling Biomedical Products

  • SOP of IMP Management

  • SOP of Providing Clinical Care

  • SOP of Risk, Safety and Adverse Advents (AEs) Management

  • SOP of Site Selection

  • SOP of Site Feasability

  • SOP of Staff Management

  • SOP of Study and Site Management

  • SOP of Study Close

  • SOP of Study Initiation

  • SOP of Monitoring Plan

  • SOP of Training Record

  • SOP for Document Submission

  • SOP for Laboratory

  • SOP for Pharmacy

  • SOP of Data Entry

  • SOP of CRF completion

  • SOP of Data Security

  • SOP of CRF Scanning

  • SOP of Informed Consent and Counselling

  • SOP of Protocol Adherence

  • SOP of Quality Assurance

Clinical Research, Tunisia, Africa, Clinical Trials, CRA, SCRA, Clinical Research Associate, GCP, Monitor, Monitoring, Senior Clinical Research Associate, CRA I, CRA II, CRA III, LCRA, Oncology, Cardiovascular, Neuroscience, Immunology, Infectious Diseases, Metabolism, Field Based, Home Based, CRO, Pharmaceutical