Every clinical trial starts with the preparation of a detailed research protocol. But the question here is, are these protocols really necessary or are they simply some sort of formalities which place additional burden on researchers just to turn into an ever-growing pile of documents at the end?
To start with, let’s define what protocols in clinical trials really stand for. A protocol represents a formal document which indicates all of the significant elements of a trial’s program. It is extremely useful especially when there is a collaborative work between researchers, investigators and other sides at different locations. Going further, research protocols also ensure the wellbeing of patients, their privacy as well as confidentiality and integrity of data.
There are various sections covered in the protocol and every single sections points out different specifics which are important and help researchers, sponsors and other practitioners in their work and activities. In essence, those sections offer information about the study organization, design, background, methodology, timetables and schedules of laboratory tests, goal(s), medicaments, dosages, criteria for patients’ study inclusion and exclusion and, finally, statistical considerations.
However, even in the strictest practices in clinical trials, there appear to be certain deviations and violations. Even though almost every clinical trial experience deviations, their number should be minimum. In case there is a severe deviation that puts the safety or patients at risk, the event should be immediately reported to the IRB. A protocol variation, on the other hand, represents serious departures from acknowledged processes and procedures which may negatively affect the validity of the trial, as well as its evaluability and results.
Trying to avoid such disadvantages and hindrances to the study progress, experts have suggested several good practices which include:
- Providing adequate information and proper training to all technologists that may be participating in the scanning of research volunteers
- Keeping and providing a copy of the research protocol not only to the research department but to the technologists as well
- Reviewing the protocol on a regular basis
In conclusion, preparing a study protocol is really important when it comes to performing successful studies. This kind of detailed protocols contain crucial information about the trial participants and the study itself. Going back to this data and plan will reassure practitioners that things are going the right direction. To put it differently, they will know that they are carrying out the procedures in accordance with all of the requirements which will really save them time, cost and efforts.
Research Protocols in Clinical Trials is one of the topics that will be covered in our next webinar on Clinical Data Management Advanced Electronic Data Capture Systems. The webinar will discuss the process of collection, cleaning, and management of subject data in compliance with regulatory standards. The online training session is certified and is taking place on 12-th November 2015. Hurry up and get the Early-bird registration until 5th November, 2015.
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