Quality policies and SOPs

We have developed in house standards and policies which are available on our intranet or upon request by interested parties. Their purpose is to govern and assure quality is achieved and maintained, and that all regulatory requirements are adhered to. These sets of policies and standard operating procedures (SOP) are reviewed and updated regularly and currently they include:

POL- 001 Health and Safety
POL- 002 Training
POL- 003 Quality Improvement
POL- 004 Clinical Lab Management

CTF's SOPs cover the following areas:

1. Administrative

SOP 1.0 Preparation, Approval, Review and Issue of clinical trial SOP
SOP 1.1 CTF Standard of operation
SOP 1.2 Pharmaceutical product management and accountability
SOP 1.3 Preparing a trial budget and contract

2. Regulatory and QA

SOP 2.0 Protocol generation and submission
SOP 2.1 Informed consent
SOP 2.2 Consent on HIV screening
SOP 2.3 Participant confidentiality

3. Clinical Trial conduct

SOP 3.0 Study initiation procedure
SOP 3.1 Good documentation practices
SOP 3.2 Adverse/ Serious Adverse Events (AE/ SAE)
SOP 3.3 Phlebotomy
SOP 3.4 Ongoing trial management
SOP 3.5 Monitoring
SOP 3.6 Data entry and management
SOP 3.7 Community engagement and MOH liaison
SOP 3.8 Study close out