1

1.1

Report providing an overview of processes at regulatory bodies, IRBs and trial sites

6

1.2

Competency Assessment of clinical trial investigators

6

1.3

Analysis report (strengths, weaknesses and gaps)

6

2

2.1

Training reports (12 trainings/consultative meetings and 4 workshops)

2, 4, 5, 6, 9, 12

24

2.2

Report on Workshop on review of SOPs

3

2.3

Action plan for improvement of functioning (including timelines and responsibilities)

9

2.4

Training schedule

9

2.5

SOPs and guidelines on emerging clinical trial priorities

12

2.6

Customised training curriculum for the NEC, IRBs, clinical trial investigators and NRA  

12

3

3.1

10 staff members each from the NEC and NRA complete short-term courses/

workshops on Clinical Trials Inspections/

audits, Data and Safety Monitoring, Protocol review and assessment, Good Clinical Practice Guidelines (Reports on the training)

6, 9, 12

3.2

Report on learning and scientific visits to Centres of Excellence within the region

12

3.3

Report on benchmarking exercises

12

4

4.1

Set up and use of electronic system

18

4.2

Report on training users on the electronic system

18

4.3

Report on use of the system (e.g. how many protocols submitted and reviewed)

24

5

5.1

Project Officer recruited

3

5.2

Project assistant recruited

3

5.3

Activity plan

3

5.4

IRB office set up at the main referral hospital

6

5.5

Monitoring and evaluation plan

6

5.6

Results framework

12

6

6.1

Dissemination and Exploitation Plan

6

6.2

Data Management Plan

6

6.3

Project website/webpage

6

6.4

Project newsletter

6, 12,

18, 24

6.5

Social media (Facebook, Twitter)

6

6.6

Profile on Research Ethics Web (http://www.researchethicsweb.org/)

6

6.7

Participation in the EDCTP Forum 2021

7

6.8

One publication on the clinical trial landscape in Botswana (open access)

18

6.9

Presentations (e.g. AVAREF and World IRB)

18