A clinical study protocol is a document that indicates how the clinical trial is going to be conducted. Clinical Project Managers and Clinical Research Associates (CRAs) usually work on one study/protocol at a time. They also need to train clinical sites and answer questions from PI or study staff; so, having a great understanding of the protocol is critical in these roles. Clinical Research Coordinators (CRC) also needs to have comprehensive knowledge about the study protocol because she/he is the key person helping the PI to conduct the trial. Therefore, study protocol is the first step towards getting involved in a clinical research project. If you just started a clinical research position or you are placed on a new trial you might get confused with the long clinical protocol documents.
Here are three sections you need to focus on if you donāt have enough time to read the whole protocol or if it is the first time you are reading a protocol:
Inclusion/Exclusion Criteria
The eligibility criteria are the most important factor once reading a protocol and subject enrollment basically depends on this section. Inclusion Criteria are the criteria that a subject must have in order to be included in the study and Exclusion Criteria are the factors that would make a subject ineligible to be enrolled in a study.
If you donāt have experience in clinical trials and never reviewed a clinical study protocol, I suggest to visit clinicaltrials.gov. In the search bar of the website, include the field of research you are mostly interested in (e.g. Oncology, Psychology, GI, etc.) and take a look at the eligibility criteria or inclusion/exclusion criteria at different studies to have a better idea of this section.
Schedule of Assessments
Most of the clinical trial protocols have a table titled as āSchedule of Assessmentsā. This table represents the summery of assessments that need to be done from the āPre-screeningā through the āEnd of Study Treatmentā. This table helps the study staff to track every single steps of the trial.
Protocol Synopsis
You can find protocol synopsis of a study at the first pages of the protocol. This section is really helpful especially for busy CRCs; coordinators can print this section and give it to the PI for his/her review. Also, if a CRC have multiple studies in a site and needs to refresh his/her mind, this section will be a good cheat sheet.
After reviewing these three sections in the protocol you will have an idea about the study, and you can go over other sections as needed.
Last but not least is the Protocol amendments. If there are any changes in the protocol, the sponsor will release a protocol amendment. Since Clinical Project Manager and CRAs usually work on one project at a time, itās easier for them to remember any changes in the protocol. However, a CRC might be busy with several studies so, as a CRC you always want to keep your site organized by placing the most recent files somewhere you can find it easily.