Introduction, Background and Purpose
An initiation visit is performed to ensure the investigators and study staff understand the study protocol, that all the operational steps are in place, and that everyone is clear and well trained in their specific roles and responsibilities. A trial initiation visit is conducted prior to the first patient being recruited into a study. These meetings are important whether the trial is commercial, non-commercial or academic, and for any type of intervention.

The visit is usually conducted by the trial coordinator or often a monitor on behalf of the sponsor. Essentially their aim will be to work with the sites to ensure that the site’s planned operational procedures fits with the requirements of the protocol and will ensure accurate data as well as safe and ethical conduct of the trial.

The initiation visit is held once sites have had their regulatory and Ethics approval in place and after all the essential documents have been retrieved for the site and sponsor files.

There are a number of items that may be discussed at this visit:

- Study protocol (study objectives, purpose, endpoints)
- Reporting AEs and SAEs
- Investigational drugs (storage, dispensing, destruction, accountability) or any procedures necessary for other types of intervention
- Inclusion/Exclusion criteria of protocol
- Patient Enrolment (including withdrawal criteria)
- Case record form completion and error correction
- Protocol compliance and deviation issues
- Quality management

In some cases, the sponsor may decide to waive the initiation visit either in particular sites or overall across the study. For instance where the sites have been used for a similar study previously, for simpler studies where the study procedures are straight forward and easy to follow or where the sponsor has decided that the investigator meeting will also act as the initiation visit.

Where this occurs, it should be made clear and documented in the study files what training has occurred to replace the initiation visit.

Preparing for the Initiation Visit

- A meeting room should be available
- A site checklist is used by the monitor or trial coordinator to ensure that all items have been covered during the initiation visit.
- The monitor should check that all regulatory documents have been retrieved prior to the meeting. It is possible to retrieve the last of the documents at the initiation visit provided the site has confirmed that they have these documents at site for collection.
- All trial staff should also be available at the visit. This includes the principal and sub investigators, study coordinators; pharmacist etc. if they can’t be all available at the same time, the monitor could split the visits over several times in the day to meet with all members of the trial team.

During the Initiation Visit

A useful technique for planning an initiation visit is the ‘trial walk-through’. Here those in the meeting work through the whole study from (usually) the perspective on a participant. This helps see how the trial will run on the ground logistically and enable any potential glitches to be identified. For example working through the process for a vaccine trial might work as follows;

1. Community engagement in the study areas to explain the planned trial with community leaders and then the whole community
2. Mothers present at clinic and are approach as a group to explain the trial
3. One to one consent discussions with each mother with a study nurse
4. Consent taking by clinical officer
5. History of child taken and blood sample
6. Sample labelled and prepared for cold transportation to laboratory
7. Child vaccinated
8. Mother reminded of follow up visit and contact details of locally based field worker
9. Samples transported back to lab within 3 hours
10. Samples received and processed in trial lab
11. Any abnormal lab results reported by to investigators
12. Follow up visit one
13. Adverse event reported and child needing treatment
14. Child late to next follow up visit and needing finding in community
15. Next follow up visit completed
16. Child ends trial

Going through the whole trial journey from the participant’s perspective enables many of the potential outcomes to be thought about beforehand and therefore enables the staff team to be prepared.

Generally a trial initiation visit should cover the following;

- All aspects of the study should be discussed as mentioned above but also to include lab sample collections, method of randomisation (where necessary), advertising and any other matter that needs clarification.
- Where the study medication is already on site, the monitor will check that it is stored correctly and plans for dispensing have been agreed by the PI and Pharmacist.
- Ensure that all participants have completed the site personnel log.
- Check that sites have sufficient study materials such as CRFs (where necessary) lab kits and any other study specific kits for sites to start recruiting.
- Discuss the site arrangements for archiving the study documents at the end of the study.
- Retrieve the site contact details and establish the frequency of monitoring visits.
- Retrieve any last bit of documentation (where applicable).

Post Initiation Visit
- The monitor will complete the initiation report and file a copy of the report in the site file.
- Any actions from the meeting will also be addressed and a follow-up letter forwarded the site to clarify any questions that were raised at the meeting.