Standard Operating Procedures for Clinical Trials

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:

  1. Administrative (Download PDF Bundle - 93KB Zip File)
    1. Procurement
      2.  
    2. Attendance
      3.  
    3. Vehicle use


     

  2. Clinical (Download PDF Bundle - 1.6MB Zip File)

    3.    

    1. Clinic Flow policies &  procedures
      2.  
    2. Clinical research management plan
      3.  
    3. Consent
      4.  
    4. Protocol implementation
      5.  
    5. Source documentation
      6.  
    6. Essential documents
      7.  
    7. Office charts
      8.  
    8. Study visits and missed visits
      9.  
    9. Study medications
      10.  
    10. Toxicity management
      11.  
    11. Subject recruitment
      12.  
    12. Subject logs and codes
      13.  
    13. Transportation reimbursement
      14.  
    14. Ethics committee submission checklist
      15.  
    15. New protocol evaluation survey
      16.  
    16. Orientation manual
      17.  
    17. Quality management plan
      18.  
    18. Research coordinator checklist
      19.  
    19. Study nurse checklist
      20.  
    20. Monitoring visits
      21.  
    21. Regulatory affairs
      22.  
    22. Signatures
      23.  
    23. Site assessment
      24.  
    24. Site responsibility
      25.  
    25. Patient and study identification numbers
      26.  
    26. Safety reports
      27.  
    27. Training record
      28.  
    28. Venipuncture

     
     

  3. Data Management (Download PDF Bundle - 92KB Zip File)

    4.    

    1. Data entry
      2.  
    2. Case report forms (CRF) completion
      3.  
    3. CRF scanning
      4.  
    4. Data security
      5.  
    5. Definitions
      6.  
    6. Filing
      7.  
    7. International communications
      8.  
    8. Query resolution
      9.  
    9. Power failure during data entry
      10.  
    10. CRF quality assurance
      11.  
    11. Table of contents

     
     

  4. Laboratory (Download PDF Bundle - 2.9MB Zip File)

    5.  

    1. Over 60 SOPs regarding laboratory equipment, supplies, and tests

     
     

  5. Pharmacy (Download PDF Bundle - 316KB Zip File)

    6.    

    1. Labels
      2.  
    2. Infant prescriptions
      3.  
    3. Pharmacy plan
      4.  
    4. Study accountability records
      5.  
    5. Post trial ARV access
      6.  
    6. Refrigerator temperature logs
      7.  
    7. Room temperature logs
      8.  
    8. Site pharmacist checklist
      9.  
    9. Policies and Procedures
      10.  
    10. Disposal of unfit pharmaceuticals
      11.  
    11. Disposal of unfit products
      12.  
    12. Importing study products
      13.  
    13. Prescription numbering
      14.  
    14. Drug transfer form
      15.