Standard Operating Procedures for Clinical Trials (SOPs)

The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. DGHI is pleased to share these documents with others who are working in resource-limited locations. Although most of these SOPs were developed for AIDS clinical trials, many of these documents can be modified and extrapolated to meet your specific project needs.

SOPs are available in the areas of:

Administrative  (Download PDF Bundle - 93KB Zip File)
  • Procurement
  • Attendance
  • Vehicle use

Clinical  (Download PDF Bundle - 1.6MB Zip File)

  • Clinic Flow policies & procedures
  • Clinical research management plan
  • Consent
  • Protocol implementation
  • Source documentation
  • Essential documents
  • Office charts
  • Study visits and missed visits
  • Study medications
  • Toxicity management
  • Subject recruitment
  • Subject logs and codes
  • Transportation reimbursement
  • Ethics committee submission checklist
  • New protocol evaluation survey
  • Orientation manual
  • Quality management plan
  • Research coordinator checklist
  • Study nurse checklist
  • Monitoring visits
  • Regulatory affairs
  • Signatures
  • Site assessment
  • Site responsibility
  • Patient and study identification numbers
  • Safety reports
  • Training record
  • Venipuncture
Data Management (Download PDF Bundle - 92KB Zip File)
  • Data entry
  • Case report forms (CRF) completion
  • CRF scanning
  • Data security
  • Definitions
  • Filing
  • International communications
  • Query resolution
  • Power failure during data entry
  • CRF quality assurance
  • Table of contents

Laboratory (Download PDF Bundle - 2.9MB Zip File)

  • Over 60 SOPs regarding laboratory equipment, supplies, and tests

Pharmacy (Download PDF Bundle - 316KB Zip File)

  • Labels
  • Infant prescriptions
  • Pharmacy plan
  • Study accountability records
  • Post trial ARV access
  • Refrigerator temperature logs
  • Room temperature logs
  • Site pharmacist checklist
  • Policies and Procedures
  • Disposal of unfit pharmaceuticals
  • Disposal of unfit products
  • Importing study products
  • Prescription numbering
  • Drug transfer form