A clinical study report is a document that gives the complete, verifiable, and accurate picture of a clinical portion of a study. The ideal approach to preparing a great clinical study report involves a combination of accurate extraction of data from documents, analysis of information and presenting in the required format without misrepresenting any result or fact from the actual document. There are ten steps that can ensure an excellent clinical study report.
STEP 1: Format and structure of a clinical study report
This should be as per ICH (International Conference on Harmonization) E3 – Structure and Content of Clinical Study report and as per the applicable regulatory for which the study needs to be submitted (US-FDA, UK-MHRA, Australia-TGA, etc.). The ICH E3 provides a basic skeleton for a clinical study report with the essential contents clearly mentioned and explained along with ready-to-use appendices.
Tip: Prepare a template of the clinical study report as per ICH E3 and modify according to the study requirements and regulatory requirements.
Step 2: Entering study protocol contents
The Study Protocol shall contain essential elements such as investigational drug name, test and reference drugs’ manufacturers’/distributors’ names, dosage strength, dosage period, duration of study, number of subjects/patients, principal investigator and clinical investigator names, the medical facilities and other clinical services to be used in the study, study design, randomization of the drugs to be administered to the patients/subjects and the entire study procedure. These need to be entered in the relevant sections of the clinical study report.
The protocol captures the events that ‘must’ be done in a study whereas a clinical study report captures whether these events ‘actually happened’ as stated in the approved protocol.
Step 3: Analysis and incorporation of clinical data
The clinical data received should be reviewed for critical events such as dose administration and duration of treatment, adverse event reporting and documentation, diet, etc. as stated in the protocol. The extraction of information and incorporation in the relevant section depends on the sense of analysis that the author possesses. The author of the report must ensure that all the events that were compliant with the study protocol as well as those that are non-compliant with the protocol are captured.
Step 4: Incorporation of statistical data
The statistical data from WinNonlin software or SAS software, whichever is applicable as per the study protocol should be incorporated in the relevant section indicating clearly the number of subjects enrolled in the study and those that completed the study and the reason behind the difference as per clinical data. The randomization schedule along with the statistical tables and graphs should be appended to the study report in the relevant appendices.
Step 5: Protocol deviations
All protocol deviations must be captured as per adequately documented reason and corrective action taken. The details of the protocol deviation must match accurately with the paper or e-CRF documentation done for the same. All planned protocol deviations must also be captured after adequate documentation by clinical team and approval from sponsor.
Step 6: Adverse events
The clinical study report must accurately describe the onset, duration, management, and resolution status, as well as the reporting time frame to sponsor and ethics committee of the adverse event as per documented adverse event forms. The required information should be captured in the tables provided in ICH E3 format or as per regulatory requirements displaying the categories of adverse event, progress, and resolution status. Other details would include tabulating the adverse events with respect to test and reference investigational products which is also called extent of exposure.
Step 7: Demographics
Demographics would include the physical and habitual characteristics of patient population such as Age, height, weight, sex, race, smoking and alcohol consumption etc. The demographics of the patients that were screened for the study and those that completed the study are tabulated and presented with statistical measures such as mean, median, minimum and maximum, and percentage. The minimum and maximum measures indicate the range of patient population and are described in a subjective paragraph as well.
Step 8: Tables, listing, graphs and appendices
The appendices should be prepared as per the heading stated in ICH E3 and relevant data (either photocopy or the original as applicable) shall be kept in the corresponding appendices. Tables, listings and graphs shall vary as per the regulatory requirement but must be concise, accurate and indicating the required information.
Step 9: Format ting and English
The header, footer, font type, font size, sub-headings, and margins must remain consistent for all portrait and landscape pages throughout the report. The study report must contain the report number and version number on all pages, either in header or footer along with page number such as page x of y. There should be a title page with study title, study report number, version number, date, and signature section. There should be a conclusion section that clearly states the result of the study.
Step 10: Signatures of all essential people and approval
The signatures of the principal investigator, sponsor, and other investigators involved in the study as well as the critical personnel such as statistical person(s), Quality Assurance, and author of the report should sign along with date in the respective sections of the report. The sponsor’s signature indicates approval of the report. The QA statement of compliance should be kept in the relevant appendices. And last but not the least, a good audit of the clinical study report is required before submission!
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—About our writer:
Shruti B. is a clinical quality assurance professional with 4 years experience in various BA/BE and clinical trials CROs in India. She has expertise in internal auditing, external vendor audits, SOP writing, clinical study report writing and audit, CTD submisssions for FDA and Canada. She is also interested in writing for children and short stories to explore her creative skills. She is working presently as a freelance medical writer and is based in Hyderabad.
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