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Once all the necessary ethical approvals are in place AND the trial has full indemnity cover AND been registered then the trial can begin.
Before recruitment commences a site initiation must be done by the sponsor or designee such as a Contract Research Organization (CRO). If the trial is being monitored then the monitor should conduct the initiation visit. If there is no monitor then the study manager or investigator should formally initiate the trial. The person performing the site initiation will visit the site and review the trial processes with the trial staff. For multicentre studies, the site initiation must be done at each site. It is important to keep documentation of the site initiation process in the Trial Master File.
The initiation process is important as it ensures that all the logistics are organised:
- Staff have been trained on the appropriate SOP's
- All the GCP documentation is in place
- The drug/vaccine or other intervention is ready and being properly stored and accounted for
- Laboratory sampling kits are available at the study site(s) and the lab is ready to receive the samples
You can find numerous free, downloadable templates for study initiation at Global Health Trials' templates library.
You can access an interactive map for study initiation by following this link: Global Health Research Process Map
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In addition, before recruitment commences at a site, the trial should be registered in a Clinical Trial Registry. Prospective clinical trial registration is mandatory if there is intention to publish any findings in member journals of the International Committee of Medical Journal Editors (ICMJE). The World Health Organization's Network of Primary Registries are all ICMJE endorsed and a list of them can be found at www.who.int
in addition as part of the initiation all study staff are taken through a study specific training which often is about the SOPs to be used in the study.The initiation training involves role based training -often a match between the job description /what the job is about and the person.Any difference between the job and the person are filled through training to fit into the job well.As mentioned by the administrator ICh-GCP is part of the initiation training that must be done,some ethics training for example NIH ethics training,use of equipments /tools demontration etc