This blog post is primarily about how PleaseReview can assist life science companies in the process of complying with the European Medicines Agency (EMA) transparency policy 70 on the publication of clinical data. However, it also discusses how we at PleaseTech plan to expand PleaseReview’s redaction (or masking as it is sometimes known) capability over the next six months, so this post may be of interest to those readers with other redaction challenges.
What is the EMA's transparency policy 70 and its impact on the publication of clinical data?
Without going into too much detail, the EMA’s Policy 70 concerns the publication of clinical data for medicinal products for human use (more information can be found here). This requires the publication on the EMA website of clinical data submitted by life science companies to the EMA in support of drug applications. As such, said clinical data is made publicly available to the whole world.
Pertinent to our interest, is the fact that the published documentation must be redacted to remove Personal Private Data (PPD) and Personally Identifiable Data (PID) and may also be redacted to remove some Commercially Confidential Data (CCI). So, in short, the submitting life science company needs to agree redactions (and for the CCI data, provide a justification for each redaction – the so called ‘Justification Table’) to the EMA and then provide the redacted documents for publication.
To further complicate the issue, PPD and PID data is relatively structured and standard and, therefore, can largely use a rules based approach to redaction. It is therefore a candidate for being subcontracted. Whereas CCI data is ‘softer’, typically lacking structure, and open to interpretation - so requiring justification. So, in practice, work on the different redaction types requires a different process and therefore needs to be undertaken by different teams – ideally in parallel as there is considerable time pressure.
Clearly this is a massive undertaking, especially as the policy is retrospective and therefore the documents will not have been written in a way that ever anticipated publication. So, in summary, life science companies submitting to the EMA have a short amount of time to redact thousands of documents, masking specified information only some of which is structured.
Where can PleaseReview assist?
Firstly, with the review of proposed redactions.
In my view, the redaction of a document is no different to any other document review process. Redactions must be proposed, reviewed, approved and then published. Initially, during the negotiation phase when CCI redactions are agreed with the EMA, a PDF document ‘marked for redaction’ will be the published output. Only when agreement is reached will the agreed redactions be applied to the document. At all stages review is a critical part of the process.
Proposed redactions need to be reviewed and that’s the first place PleaseReview fits in. If you are an existing PleaseReview user, your system, as it is configured today (no upgrades needed), can be used. PleaseReview will identify the areas ‘marked for redaction’ in a PDF file in PleaseReview. These can then be commented upon, discussed, agreed, etc. Areas missed can be identified. As always all this interaction is recorded and reported upon.
Secondly, with the latest and the greatest PleaseReview release (v6), not only do you get the areas ‘marked for redaction’ identified, but review participants can also propose redactions within PleaseReview. These are treated like any other proposed change to the document. As such, proposed redactions appear in the reconciliation report, which can be downloaded in Word and can therefore be copied and pasted into the Justification Table. So, collaborative redaction is introduced and available. Use it wisely!
Finally, we are busy working on v6.1 which will include several enhancements designed to streamline the process:
Redaction categorization. Precise requirements are still emerging and evolving, but initial indications are that different types of redaction (i.e. PPD, PID & CCI) will be required to have different properties (specifically color and overlay text) and so PleaseReview will include the ability to specify different redaction properties against Redaction Categories (the same as Comment Categories);
Round tripping of PDFs. It is important to be able to seamlessly import areas marked for redaction in PDF files into PleaseReview (i.e. convert them into PleaseReview proposed redactions rather than just identify them) and export them as the same so PleaseReview can be used to manipulate them (i.e. accept/reject/etc.);
Merge redactions. The ability to import PDF documents into PleaseReview with areas marked for redaction at any stage of the review cycle and have the proposed redactions imported and merged with the master document. This will allow multiple teams to work in parallel and then consolidate results;
Automatically produce a justification table minimizing manual work such as copy and paste.
So, in summary:
If you are current users of PleaseReview, with your existing system you can collaborate on the review of proposed redactions;
If you upgrade to PleaseReview v6 (the latest release), not only can you collaborate on the review of proposed redactions but also propose new redactions in PleaseReview;
When PleaseReview v6.1 is released, (Q1,17) – you will be able to do all of the above, plus you’ll also have a collaborative redaction environment, designed to assist the process of complying with the more subtle redaction requirements of Policy 70.
If you would like to learn more about PleaseReview's redaction capabilities or see a demonstration, please contact us.