To ensure success, preparations for study start should begin in parallel with protocol development. It is very common for trial teams to underestimate how long it takes to set up a trial. Furthermore, every experienced trial investigator would agree that the effort invested in pre-trial planning and preparation more than pays off in terms of smooth operations, happy staff, happy participants, good recruitment and ultimately high quality data. It takes a long period of time to get a protocol properly written, funded and taken through the necessary approval times. All this time can be well spent by getting thoroughly prepared for study start.
Global health Trials can provide all the resources and materials needed to set up a trial. The starting point for the investigator should be designating a trial team and planning weekly meetings to get the process under way and to monitor progress.
A weekly trial set-up meeting should include everyone involved (labs, clinical, data management, coordinators). Regular, face-to-face meetings allow the team to sit together and go through all the activities and ensure everything is in place.
Key documents that should be planned and written at this stage include the study-specific standard operating procedures (SOPs). A laboratory analysis plan will be needed if there is to be any sampling. The Case Record Form (CRF) and database will need to be developed and all the GCP documentation put in place. All of these elements are covered under their own subject heading and linked through this page.
If applicable, the Ministry of Health (or equivalent regulatory body) and the trial community should already have been involved from the concept proposal stage. They can now be engaged with fully to put into place a full communication and community plan which ensures that potential trial participants and the non-trial staff working in the health facility are fully informed and engaged.
You can find many free, downloadable templates on Global Health Trials' articles library.
You can access an interactive Process Map for study initiation at this link.
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