Freelance medical writers often find themselves contracted by sponsors for writing clinical trial reports (CTR) also known as clinical study reports (CSR) even before all the required documentation is ready at the sponsors end. This causes delays in the completion of the clinical study report. In addition, delayed CTR completion can extend the actual submission date of the product’s eCTD/marketing application as clinical study reports are mandatory documents for the regulatory submission dossier. Every day by which the marketing application submission gets delayed, results in a considerable loss of revenue for the sponsor.
Completion of the clinical study report must be taken on a priority after study completion and all efforts must be put in to ensure that a clinical study report is finalized within a reasonable amount of time. This will not only reduce the cost of CSR development but also result in faster submission to the regulatory authorities.
One of the best ways to ensure that the CSR is completed in time is to make an effective use of checklists by the sponsor. This will help sponsors in keeping all documents required for compiling a CSR ready in advance. A list of documents that will be helpful for medical writers when writing clinical study reports has been provided below for free download. Some of these are mandatory while others are optional and used only during special circumstances.
Assuming that the CSR will be included in an electronic regulatory submission, it is always better to hand over the documents listed in this file to the medical writer in an electronic format. Documents which are available in the form of hard copies should be scanned for incorporating into the CSR. It is better to do so by the sponsor, since the cost of the developing the CSR will be higher if medical writers have to work with hard copies than if they are provided electronic copies. This is because the medical writers will have to scan and convert the hard copies into electronic files first, so that they can be incorporated into the CSR and moreover it is a time taking activity.
Though the PDF-formatted files are sometimes useful in drafting the final report, it is recommended that medical writers should always have the protocols, amendments and investigator brochure in Microsoft Word format. This is for the reason that the medical writer has to copy and paste the data into the CSR- specific, in verbatim language taken from these documents, especially the protocol. Also, if it’s a PDF file, the writer has to type the data into the draft CSR, which might invite errors and consume more time.
Having said all this, the question that still remains is: What is the right time for the medical writer to develop a clinical study report? Ideally, both the CSR and clinical study protocol should be developed in parallel to each other. As a matter of fact, this rarely happens in the real world. The CSR template can be populated with the required information long before the completion of the study and database lock. With the availability of the SAS data, after final data analysis the CSR can be completed in a relatively less time. This way, a great deal of time can be saved and one need not wait till database lock to begin drafting the CSR!
The various documents that the medical writer requires to compose an ICH-compliant clinical study report (clinical trial report) are mentioned in the document attached below.
The list of documents mentioned in this file is not intended to be definitive. Every clinical study is different and unique in its own way and may require specific documents that have not been included in this list. Further, different regulatory agencies may have different requirements who must be consulted when preparing an ICH compliant clinical study report.