48 Things Medical Writers Need for Clinical Study Reports (CSRs)

Contract medical writers sometimes find themselves hired to write a clinical study report (CSR) (or clinical trial report (CTR)) before their client has prepared all of the information needed for the report. This leads to frustration and causes delays in the CSR’s development. In turn, delayed CSR completion can extend the actual submission date of the product’s eCTD/marketing application-because CSRs are required content. Thus, the very painful result of delayed CSR preparation is the sponsor’s loss of considerable revenue for every day that the marketing application’s approval is delayed.

Stack of cashClearly, writing the CSR promptly, on study completion, is the wise course of action. Doing this can reduce the cost of generating the CSR, compared with writing the CSR months or even years after the study is closed. And one of the most effective things the sponsor can do to prepare for prompt CSR completion is to have the items listed below available when the medical writer begins drafting the CSR.

The items in this list include some documents and tools that must be available for CSR completion. However, some items are optional. Other items are needed only in specific circumstances, such as when specific clinical trial designs are used. This checklist applies to full-length CSRs that document the execution and completion of clinical studies of drug and biologic investigational products.

All documents listed here should be provided to the medical writer in electronic format, assuming the CSR will eventually be included in an electronic regulatory submission. If the documents are available only as hard copies, those should be scanned for incorporation into the CSR. If the writer only receives hard copies of the documents they need to work with, the cost of the CSR will be much higher than if they are given electronic copies. This is because the writer will have to scan the hard copies to convert them into electronic files in order to incorporate them into the CSR, which is a time-consuming activity.

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