Table 1 Monitoring activities

1. Regulatory documents

• Approvals: REC, UNCST and NDA

• If approval is valid

• Availability of study related docummnets

• Case report forms

• Communication with collaborators

• Data collection forms

• Valid practicing licenses

• Study brochures

2. Site facilities

• Recruitment area

• How many studies being conducted at the site

• Availability and the amount of space compared to the participant population

• Laboratories

• Approval status for all studies

• Approval letters

• Clinics,

• Number of staff for the study

• Available staff

• dispensing areas,

• storage facilities for drugs and other study materials,

• data management areas,

• study staff

• Record offices

3. Informed consent process and documentation

• Signed informed consent forms

• How it is obtained

• Observe the process of obtaing consent

• Who witnesses

• How long it takes

4. Participant welfare

• Amount approved in consent form

• How much is given

• Signature by receipient

• How amount is determined

• Who gives out the cash

• Ask participant what they get

5. SAEs management and reporting

• Records of identified SAEs and their management

• How identified

• SAE reports

• Signed SAE reports

• How managed

• Status of the SAE

6. Study related training

• Training certificates

• When trained

Training certificates

• Who trained

Ability to perform as trained

• Importance of the training

• Knowledge of regulations and study

7. Working practices

• Minutes of meetings

• Frequency of meetings

Meeting minutes

• Communication memos

What is discussed in the meetings

• Communication with collaborators

How long the meetings take

• Availability of SOPs

• Delegation logs

• Explaining of procedures

SOPs at work stations

8. Debriefing

Communicate findings of the monitoring team and get feedback from research team