Clinical Trial Protocol
Clinical trial protocol is the essential document designed in early stages of every clinical trial. It contains the main information of the works carried out: the purpose of the study, the objectives, study scheme, the methodology used, statistical data, and other organizational issues.
Data unification lets the protocol make the work of study sites more available and transparent. A quick glance to the document lets any healthcare professional understands the relevance and effectiveness of the proposed study; only after that a decision is made on study feasibility.
Along with general data, the protocol contains clear instructions, defines the objectives and delegation of duties for each study member. If the protocol is properly designed, due conduction of even the most complex studies becomes possible. Obtained results are further systematized, analyzed and sent to the regulatory authorities for review.
Clinical trial protocol sections
Clinical trial protocol contains the following sections which sequence is strictly regulated:
- Introduction. This section explains the relevance of the problem studied.
- Second section indicates the study goals and objectives
- Third section contains the time limits of the study
- In this section, the number of study subjects is specified.
- Informed consent of the subjects.
- Review of the Ethics Committee, that must ensure compliance of the ethical standards during the study.
- Selection criteria for the subjects in the study. These include inclusion and exclusion criteria.
- Methodology. This section should contain information such as:
- study plan (including calendar plan);
- study visits’ description;
- procedures;
- efficacy outcomes;
- course of treatment.
- Security measures. In this section expected adverse events and serious adverse events are reflected. Also, section reveals possibility of compromised lab test results or other security parameters, and study exclusions.
- Clinical laboratory parameters.
- Safety parameters.
- Concomitant medication.
- Analysis of the data obtained.
- Annexes to the protocol. These should include: informed consent of the subject and patient information sheet (only one of these documents is allowed), instructions for subjects and study staff.
Above mentioned documents intended for subjects may not contain specific medical or legal terms that may be difficult for the subjects understanding. If the term may not be replaced, it should be clearly explained to the subject.
Amendments
In some cases, protocol amendments may be implemented. This is not prohibited, however, amended protocols are again submitted to Independent Ethic Committeee (IEC) for review. No study can be initiated without IEC approval.