CRF is an important factor of any clinical trial. It is the starting ingredient of the trial. It contains all the information of patients/ subjects against the source document or protocol. This is filled by the investigator or CRC (Clinical Research Coordinator) at the site after inquiring the patients. The form has many sections and it is a separate document for each individual subject.
The main sections of CRF are:
• Title Page: - the first page of CRF is the title page. It includes protocol id, subject id, site no., date of visit, initial of the subject.
• Demographic Data: - this part covers the demographic facts about the patient such as age, height, weight, BMI (Body Mass Index), sex, etc. Some nominal questions such as alcohol and smoking consumption as they might affect with the trial results. For e.g.- In the trial of Tuberculosis, Diabetes, liver sclerosis, etc the cigarette and alcohol consumption is completely prohibited. So these questions must be genuinely answered by the subject before entering the trial.
• Vitals to be measured:-the vitals such as pulse rate, blood pressure, ECG, etc should be mentioned with respective units.
• Medical History: - the subject should clearly mention about any kind of medical history. The investigator must assure about all the organs and systems such as cardiovascular, respiratory, hepato-biliary, gastro-intestinal, genitourinary, neurological, neoplasia, psychological, immunological, dermatological, endocrine, etc. the subject must not be involved in the study until and unless he/she has no previous medical history.
• Signs and Symptoms: - any sign and symptom of fever, malaise, persistent cough, night sweats, loss of appetite, chest pain or any unusual symptom found during the trial should be noted and examined.
• Physical Examination: - the physician or medical practitioner should examine the physical appearance, heart rate, lungs, abdomen, BCG, HIV test, and jot it down respectively. In the case of abnormal conditions, the details should be pointed with reason.
• Concomitant Medication: - the previous disease and medication used by the subject should be noted down in order. The particular medication, daily dose, units, reason, start date and end date should be concise in the tabular form.
• Laboratory Analysis: - the laboratory report should be included here. The details of the bacterial culture found in the sputum, gastrointestinal tract, node biopsy, bronchial wash, urine, etc should be mentioned as the positive or negative result. Antibiotic resistance of these bacteria for different antibiotics should also be shown here.
• Adverse Event: - the adverse event experienced during the trial by the patient due to the drug provided should be mentioned in the tabular form with each and every minute details like, AE, start date, end date, outcome and severity of AE,, actions taken against AE. In case of Serious Adverse event (SAE) the adverse situation is experienced by the patient during the trial which may or may not be related to the drug provided. In both the cases, the investigator should inform the sponsor within 7 days and 24-48 hrs (in case of SAE). The sponsor must inform the Ethics Committee or Regulatory Authority within 7-14 calendar days.
• Risk Factors: - the factors which are dangerous or injurious for the subject should be mentioned. For e.g. - positive HIV test, Contact with person with active TB in past 2 years, etc.
• Withdrawal: - the subject is withdrawn from the trial under the conditions where the disease under surveillance is no longer a diagnosis, the therapy has been completed, the subject has lost to follow up or the patient has refused to continue the trial, unusual death of the subject or in the case of ADR (Adverse Drug Reaction).
• Death Report: - in case of death of the subject the reason of death, treatment provided, date of death, etc should be detailed down.
• Treatment duration: - the complete duration provided to the subject should be mentioned here.
• Visit Checklist: - the checklist contains all the details which have to be considered while filling up the case report form. The person who is filling the form should check this checklist before completing this form. It has the queries so that the investigator didn't leave any column blank. The questions like, does the subject satisfy the inclusion and exclusion criteria to date, have all screening procedures been completed, has the concomitant medication page been completed, is the subject willing to proceed, has medication been collected from Pharmacy, have the dosing instructions been explained to the patient, etc.
The Case Report Form is designed by the data management team. The software like Oracle Clinical, Rave, Inform, etc is used for the designing of eCRF or Paper CRF.
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