Standard Operating Procedures (SOP) are used by LinCTU to maintain safety and to follow the regulations for clinical trials. You are welcome to download these documents, but please acknowlege the source, and tell us if you see any changes that are required.

The SOPs we use are as follows:

1. LinCTU SOP 01 Case Report Form
2. LinCTU SOP 02 Data Management
3. LinCTU SOP 03 Data Storage, Security and Backup
4. LinCTU SOP 04 Database Design
5. LinCTU SOP 05 Randomisation
6. LinCTU SOP 06 Sample Size Calculations
7. LinCTU SOP 07 Statistical analysis plan
8. LinCTU SOP 08 Statistical Principles
9. LinCTU SOP 09 Training
10. LinCTU SOP 10 Trial Closure
11. LinCTU SOP 11 Trial Initiation
12. LinCTU SOP 12 Trial Master Site File
13. LinCTU SOP 13 Site Contracts and Agreements
14. LinCTU SOP 14 Trials Supplies
15. LinCTU SOP 15 Audits and Monitoring

The SOP template is here

Terms of Reference (ToR)

The Terms Of Reference for each committee are as follows:

1. LinCTU ToR Data Monitoring Committee
2. LinCTU ToR Protocol Review Committee
3. LinCTU ToR Steering Committee
4. LinCTU ToR Trial Management Group