Preparing documents for transparency and disclosure requirements

Nicola Pearson Date published: Sep 30, 22

Within the sector of medical writing, transparency and disclosure (T&D) relates to the process of disclosing clinical data to the public and regulatory agencies. It’s a niche and specialised task performed by professionals with an in-depth understanding of regulatory requirements.

While in this blog we focus on T&D requirements in the field of medical writing, the ideas discussed will resonate more broadly with regulatory writers and professionals in other sectors.

5 key facts about transparency and disclosure (T&D) in medical writing

1. It’s often carried about by the safety team, the medical writing team or technical editors.
2. It’s a hugely time-consuming and manual task.
3. The documents that need to be reviewed are often very large (encompassing hundreds to thousands of pages). For example, CSRs, protocols and statistical analysis documents.
4. A T&D version of a document is created in the post-submission phase: after a medical writing document has been formally submitted to the regulator.
5. T&D transformations are applied to the original document that was previously submitted to the regulator—this is always a PDF document. The T&D transformations are made via redactions or anonymisations.

The pains of non-compliance

It’s important for sponsors to comply with transparency and disclosure requirements as monetary fines associated with noncompliance can be hefty—with, in some cases, additional fines added for every day that they are late. This can be a very expensive and time-consuming ordeal for sponsors.

The Regulations

European Medicine Agency (EMA)

Policy 70 requires sponsors to publish anonymised versions of clinical study reports and submission documents submitted in support of MAAs (Marketing Authorisation Application). This policy first came into effect in January 2015.

Policy 43 came into effect in October 2018 and requires submissions to be made publicly available to citizens of the EU. According to the policy, this is because openness and transparency help to strengthen the principles of democracy and good administration.  Sponsors need to ensure that their use of clinical data is transparent and disclosed.

Health Canada (HC)

The Public Release of Clinical Information (PRCI) requires sponsors to make anonymised clinical information in drug submissions and medical device applications publicly available.

U.S. Food and Drug Administration (FDA)

ClinicalTrials.gov: Section 801 of the Food and Drug Administration Amendments Act (FDAAA) requires sponsors to register studies and report study results at this online database.

Australian Government’s Therapeutic Goods Administration (TGA)

The principle of promoting community access to government information is one of the objects of the Freedom of Information Act 1982 which requires agencies to publish information and provide a right of access to documents. Its purpose is to increase public participation in Government processes, with a view to promoting better informed decision making.

The TGA has eight principles are relevant to the consideration of whether, and if so when and how, information that might be regarded as commercially confidential could be released to the public. Discover the principles here.

How do T&D requirements impact medical writing?

There are two main strategies employed when preparing documents for transparency and disclosure requirements:

• Redaction
• Anonymisation of Protected Personal Data (PPD) or PPI

Both these strategies are used to prevent the possibility that a trial participant could be re-identified by a member of the public following a clinical submission or report’s publication.

Redaction

Redaction is sometimes referred to as “black boxing”: the process of concealing information within a document so that it can’t be read.

Redaction of CCI

The redaction of Company/Commercially Confidential Information (CCI) is typically determined by the sponsor. CCI is any information contained in the submission that is not in the public domain, or publicly available, and where public disclosure of this information may undermine the legitimate economic interest of the applicant/ marketing-authorisation holders.

Anonymisation

Anonymisation is the process of rendering the personal data of a person, such as a patient, anonymous. When a T&D professional or medical writer is making anonymisations, they are looking at how they can maintain data fields within a document while applying transformations to them to anonymise the data.

Transformations and data “keys”

In order to ensure that a subject cannot be re-identified beyond the scope of the document (e.g., a patient within a clinical study report), transformations are applied to the data. What we’re essentially doing is creating keys. We go through a patient’s data, take an old value and apply a transformation to it to create a new value. For example, their specific age may be replaced by an age range. Other data fields that may be transformed include sex, race, ethnicity and geography.

Maintaining the readability and accessibility of the document

Unlike redactions, which cause visual breaks in the continuity of the document by blacking out text, anonymisations do not disrupt the reading experience. In this way, they make the document more accessible to members of the public without exposing a patient’s identity.

An anonymisation report

When the sponsor submits an anonymised clinical report to the regulator, this must be accompanied by an anonymisation report. This details the methodology used in the anonymisation of the submission. It must also explain how the chosen approach has managed the risk of re-identification.

Managing your submission

It is important to note that managing your submission for T&D requirements is a costly and time-consuming process. Those responsible need to go through and thoroughly review the entire submission document from start to finish.

Key things to remember:

1. Redactions/anonymisations are applied to PDFs in the post-submission phase.
2. You must ensure T&D on every single page—the regulators do check thoroughly.
3. The work must be performed manually.

Common problems

Working with PDFs

• Redactions and anonymisations for T&D requirements are applied to the documents after the original documents have been formally submitted to the regulator. This means that T&D transformations must be applied to the documents in their finished PDF formats rather than as draft Word documents.
• The PDFs contain bookmarks that were included in the original submission.

Can software automate the process?

• There are tools on the market that can help. However, the process of manually checking each page cannot be avoided.
• Formatting inconsistencies, hidden characters, scanned pages and hand-written signatures are often not picked up by AI tools. This means that the software can miss important fields that need to be redacted or anonymised.
• While software can help, manual review effort remains absolutely necessary. The T&D specialist must check each page.

Costly

There is a high cost associated with taking documents past their initial submission to the regulator and re-working them for T&D requirements.

Why?

• This is a downstream effort
• The T&D workflow is often completely separate from the initial medical writing process
• You may be charged a per page fee for processing. If you have 100,000 pages that need to be reviewed for redactions or anyonymisations, and each page costs $5, the price is very high.
• The cost typically includes manual review in addition to assistance from a tool or software.
• The cost may be based on hourly rates. The human effort involved in reading an entire page from top to bottom is very timely and, ultimately, costly.

Time spent on T&D requirements

Whether you are working with a software tool or a large team of transparency specialists, the process of meeting transparency disclosure requirements is highly time-consuming. Because of the likelihood that an automated tool will miss something important, an individual must manually review submission documents from start to end again. This is to ensure that all the appropriate data fields are captured and addressed.

Things to remember

• Note that regulators do perform thorough, tedious and in-depth reviews of documents that are submitted for T&D checks. They look at every page and identify inconsistencies.
• When a regulator gets in touch with a sponsor and asks for the document to be submitted with T&D transformations, there are tight turnarounds. For example, you may have two weeks to go through 50000 pages!

Medical writers can adopt best practices for transparency and disclosure requirements

Medical writing efforts should have transparency and disclosure in mind from the very start. This means taking an “upstream”, rather than “downstream”, approach to T&D.

By making documents as transparent as possible from the start, this can significantly reduce the burden on teams who must respond to a regulators’ requests for a T&D-ready document post-submission. They will also be able to handle regulatory authority requests with greater confidence.

There are ways of including PPD in your doc that make it easier to redact or anonymise that data later

• Reduce/eliminate gender specific pronouns. E.g., you can refer to ‘the participant’ of ‘the patient’ instead of her/him.
• Eliminate dates. Only mention study days – no need then to look at all dates across doc.
• Ensure dates DO NOT break across one line of text. This is because it is a trickier field for software to recognise as a date.
• Avoid jamming text in tables
• Generalise geographies

How technology can help

While preparing documents for Transparency and Disclosure requirements is not work can that be automated or rushed, software can help you save on time and cost while also increasing the quality of documents.

Ideagen PleaseReview is a document co-authoring, review and redaction platform used widely by medical and regulatory writers across the globe.

Key benefits for T&D specialists:

• High volume teams can work in real-time on complex document reviews in a structured and controlled manner—with a full audit trail.
• Its advanced redaction capabilities make it easy to comply with industry regulations and guidelines concerning Transparency and Disclosure.
• The real-time collaborative environment also helps teams to identify CCI from the start and work together to reduce the need for anonymisations and redactions across the document.

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