Take part in our survey of review authors' views and experiences of accessing regulatory documents

Posted on 29 July 2016

We are seeking views from authors about using information from regulatory documents such as Clinical Study Reports (CSRs) in their systematic reviews. We have already surveyed Cochrane review authors and are now seeking the views of non-Cochrane review authors. The survey is part of project aimed at developing guidance for including data from regulatory documents in systematic reviews.

Reporting bias is widespread and can lead to distorted representation of trial results in journal publications. This could undermine the reliability of systematic reviews that use data extracted from such publications.

Clinical Study Reports (CSRs) produced as part of the pharmaceutical licensing process, which are much more detailed than journal articles, are becoming increasingly accessible as a result of transparency and data sharing initiatives. Data from such reports could supplement or replace information from publications.

We are developing guidance, exploring the rationale for and readiness to consider such documents in systematic reviews. We want to find out what has previously motivated authors to use CSRs and other data from regulatory documents. More generally, we want to understand levels of familiarity with regulatory documents and any barriers to using them in systematic reviews.

We are therefore seeking views from authors who have and who have not considered using information from regulatory reports in their systematic review(s).

Please note that these links are for systematic reviews that are NOT Cochrane reviews (Cochrane reviews are covered by a separate survey).

If you have previously sought CSRs or other regulatory documents for inclusion in a review (i.e., requested information and may or may not have received anything)
Please click here: https://york.qualtrics.com/SE/?SID=SV_eEsUI8TdRvxWI6N
If you have considered using CSRs or other regulatory documents but decided against it (i.e., no requests for regulatory information were made)
Please click here: https://york.qualtrics.com/SE/?SID=SV_eRGA281MipBKhF3
If you have never contemplated seeking CSRs or other regulatory documents
Please click here: https://york.qualtrics.com/SE/?SID=SV_29lpcUq6jMZEN9P

The above links will direct you to short on-line surveys that should take no more than 10 minutes to complete. Participation in these surveys is entirely voluntary, and responses will remain anonymous.

Thank you for your help.