Protocol design and Data collection

A clinical trial protocol is a document used to gain confirmation of the trial design by a panel of experts and adherence by all study investigators, even if conducted in various countries.

The protocol describes the scientific rationale, objective(s), design, methodology, statistical considerations, and organization of the planned trial. Details of the trial are also provided in other documents referenced in the protocol such as an Investigator's Brochure.
The protocol contains a precise study plan for executing the clinical trial, not only to assure safety and health of the trial subjects, but also to provide an exact template for trial conduct by investigators at multiple locations (in a "multicenter" trial) to perform the study in exactly the same way. This harmonization allows data to be combined collectively as though all investigators (referred to as "sites") were working closely together. The protocol also gives the study administrators (often a contract research organization) as well as the site team of physicians, nurses and clinic administrators a common reference document for site responsibilities during the trial.
The format and content of clinical trial protocols sponsored by pharmaceutical, biotechnology or medical device companies in the United States, European Union, or Japan has been standardized to follow Good Clinical Practice guidance[13] issued by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).[14] Regulatory authorities in Canada and Australia also follow ICH guidelines. Some journals, e.g. Trials, encourage trialists to publish their protocols in the journal


Data collection

A well-designed CRF regarding laboratory data collection captures key parameters that provide a


link to the central laboratory. In a multi-center study, a central lab may be used to analyze the

blood samples and provide the results in an ‘analysis-ready’ dataset. It minimizes transcription

errors and ensures data quality control. Although it may be considered superfluous to collect

sample information on the CRF, it is an important factor for validating the lab data and ensuring

that all records are in the dataset. In order to facilitate the data validation process, the CRF


should collect the sample date and time, fasting information, and accession number for each


sample taken. In addition, these data can be used to construct an integrated database. Thus, a


well-design CRF contains these well-referenced CRF components that make database design and


data validation processes more efficient.