Five seed documents are provided here for use in clinical research, which can be adapted and altered for each study. Here we provide a template concept protocol, a study protocol, a CRF, an informed consent form, and a generic SOP.
A set of 4 consent templates for clinical trials, interview studies, observation studies and sampling only studies.
Laboratory data is crucial in ensuring subject safety and determining the effectiveness of an investigational medicinal product. Here are some issues to consider for clinical trial laboratories in resource-poor settings.
Ticking the last box: once the trial has ended it is important to ensure correct site closure and archiving of study files.
The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.
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.
Good data management practices are essential to the success of a trial because they help to ensure that the data collected is complete and accurate. This article contains some tips to help you get started with data management.