Clinical Research or Clinical Trial Research is very important to medical science as it is the knowledge received from these studies, the data received from these ventures that help in the opening of new avenues in the field of advanced medical treatment. Various organizations, physicians, medical institutions and pharmaceutical companies may be some of the sponsors of these clinical trial researches to name a few.
The first step after deciding on the participants for a Clinical Research Trial is the filling of the Case Report Form, this is the companion all through the journey for both the research team as well as the participant. Though, they may be oblivious of the identity of the other.
A case Report Form or a CRF is a questionnaire used in Clinical Research or more specifically in Clinical Trial Research. Originally it used to be printed but these days it is being made electronically too, as is everything else. These are called “e CRF “. The advantages that an “eCRF” has over a paper, CRF is that it is more accurate, can be easily filed and kept a record as it uses less space; it has high security and is environment friendly.
A CRF is of high importance in clinical research, we can even call it the backbone of a research because it houses all information regarding the patient participating in a particular study. It is used by the sponsor of the clinical trial to collect data from each patient who is participating. It houses all information gathered from the patient that includes his case history too. Thus all data from each participating patient is collected and filed in a CRF and is kept to be used for consideration and future reference during the study. All data obtained about the patient during the clinical trial are recorded in the CRF but are de-identified by replacing the patients name and by giving him a unique number before being sent to the sponsor of the study.
Various steps come into being when it comes to making a CRF form. The first step may be the blue print of a form or a template. As far as possible the template should be easy to fill a kind which is not complicated. It should have clear instructions to enable the personnel to complete the form without any ambiguity; they should be able to clarify even unknown data like filling in a notation in place of the unknown value .The language used should be easy to understand.
Next come the various types of data entries basically they are of 3 types–
Non Time dependent data is information regarding subject demographics and medical history of the patient or the participant.
Time dependent data is data collected over visits during the investigation. For this kind of entry there are two types of layouts one is that which makes entries per visit and one that makes cumulative log entries of results collected over multiple visits. The per visit entry is preferred for physical examination or laboratory data and the cumulative log method is preferred for assessments such as vital signs which involve fewer number of parameters.
Cumulative data is data collected over time, adverse events and concomitant medications fall in this category.
Well designed and good CRFs use different icons for different response this helps in obtaining a certain consistency in data forms. A well designed Case Report Form reduces time on questions related to obtained data thus increasing the efficiency statistical analysis and output generation.