While each reviewer and collaborator involved in the study is responsible for becoming familiar with the protocol, the protocol organization should design it in such a way that details are easy to find quickly. Since the clinical trial protocol is the most important document that ensures that critical aspects of the study are communicated to all parties involved, you need to invest enough time in development. In addition, you should pay particular attention to the objectives of the study, the design, type and timing of the evaluations in order to avoid possible inconsistencies in the final document. A well-written and detailed protocol increases the likelihood of obtaining high-fidelity data, minimizes the need for protocol changes, and facilitates the preparation of other documents such as research protocols, manuscripts, presentations, etc. While the details are important, you don`t want to be so detailed that the procedures don`t become operationally feasible. Some flexibility in language may be required to allow the collection of important information without triggering a deviation from the protocol. A possible example can be found below: If you are participating in clinical trials, you may need to contribute to the creation of a clinical trial protocol. A clinical trial protocol is a document that describes how a clinical trial is conducted, including the objectives, design, methodology, statistical considerations, and organization of the study to ensure the safety of participants and the integrity of the data collected. The protocol also provides the context and rationale for conducting the study and the research questions it addresses, as well as considerations on ethical issues. The format and content of clinical trial protocols are standardized and follow the Good Clinical Practice (GCP) Guidelines (first published in 1995, last updated in 2016) in accordance with the International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH). For example, key elements of a clinical trial protocol are also provided in the study summary pages on Lilly TrialGuide (see this sample lupus study) and on ClinicalTrials.gov. These elements are also made available to clinical trial participants through the informed consent form, which is a summary formulated in a more patient-friendly manner.

Participants in CoDESIGN workshops may also receive a summary of the draft protocol in preparation for the workshop discussions and activities. An alternative to flexible formulation is to include details that are not essential to the study design in a study procedure manual (or PMS). The use of an PMS can allow minor changes to be made during the study without the need for a protocol change. A research protocol is a document that describes the context, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. When developing the protocol, consider whether flexible wording or PMS is useful to avoid discrepancies while allowing for the collection of high-quality data, or whether stricter language is required in the protocol (e.B. in cases where flexibility could affect the quality of the data and thus the validity of the conclusions drawn from it). Direct access to source data/documents The sponsor must ensure that the protocol or other written agreement specifies that the investigator(s)/institution(s) authorizes audit-related oversight, audits, IRB/IEC review and regulatory inspections and allows direct access to source data/documents. Protocol deviations are defined as accidental or unintentional changes to the protocol or non-compliance with the research protocol that do not increase the risk or reduce the benefits or have no material impact on the rights, security or well-being of the subject and/or on the integrity of the data. Protocol deviations result from the actions of the specialist or research staff.

Examples of protocol deviations include a postponed study visit or failure to collect an additional self-assessment questionnaire. An example of a protocol deviation is the measurement of vital signs before obtaining informed consent….