Challenges and opportunities in setting up a phase III vaccine clinical trial in resource limited settings: Experience from Nepal

Figures & data

Table 1. Site evaluation criteria

Site’s research interest

Support from Institution’s higher authorities/leadership/management

Available infrastructure (Laboratory/equipment/storage devices/space like area for ICF, medical history, blood draw and vaccination etc.

Availability of qualified staff/human resources

Access to well defined population/community outreach/catchment area

Community image/trust

Past experience with clinical trials/surveillance studies

Geographical feasibility/well connected transport facilities

Communication facilities (Internet/mobile network)

Media sensitivity

Budget requirements

Contract obligations

Regulatory requirements (NRA/Site IRBs)

Training requirements

Figure 1. Geographical distribution of trial sites in Nepal

Figure 2. Site assessment flowchart

Figure 3. Site staff basic requirement

Note: Back-up of each staff was ensured at each site

Figure 4. Training matrix & contracted services

Table 2. Activities observed during hands on training

1.	Informed consenting and assent process
2.	Screening & enrollment process
3.	Blood sample collection
4.	Randomization process
5.	IP administration & accountability
6.	Explaining adverse events captured in the diary card
7.	Serum sample handling, processing & labeling
8.	Development of source documents as per protocol for screened & enrolled participants
9.	Collection of source documents
10.	Data entry from source to EDC(eCRF)
11.	Capture of Adverse events in the source and EDC
12.	Capturing of concomitant medications in the source and EDC
13.	Filling of essential study logs
14.	ISF creation & maintenance
15.	Maintaining of refrigerator, deep freezer and centrifugation process
16.	Reporting of protocol deviations/violations to Ethics committee and sponsor
17.	Sending of updated recruitment trackers to sponsors/CRO
18.	Archival of study documents

Figure 5. Community engagement & communication plan