Being the writer who brings the guideline

A medical writer brings reporting guidelines into a project by identifying the relevant guidance, helping authors and sponsors understand their responsibilities, and supporting its use throughout the team's work.

Responsibilities to authors and sponsors

The AMWA–EMWA–ISMPP Joint Position Statement makes professional medical writers responsible for consulting appropriate guidelines and ensuring that authors and sponsors know their obligations under them. ¹ It encourages writers to be reporting-guideline champions. ^{2, 1} Writers should have the time and expertise to help authors identify and adhere to the relevant guidelines. ¹

At a joint educational webinar on 30 May 2018, 95% of respondents (119 of 125) agreed that professional medical writers should be guideline champions. ¹

Practical support for the team

Guideline champions can support their teams and promote good reporting through the following activities. ^{1, 3}

• Raise awareness of relevant reporting guidelines and the EQUATOR Network among authors and sponsors.
• Monitor the EQUATOR Network and alert the team to new and relevant reporting guidelines.
• Audit and update the team's training in using reporting guidelines.
• Promote the joint position statement proactively to authors and sponsors, especially by citing published evidence supporting the benefits of medical writing support.
• Advocate for and contribute to the evidence base on the integrity and value of medical writing support by conducting and publishing research.

^{1, 3}

These activities provide practical support to teams and contribute to best-practice reporting that should be valued by managers, editors, peer reviewers and readers. ¹ Advocating for the EQUATOR Network and the joint position statement may also advance a writer's career. ¹ Conducting and publishing research on medical writing support can earn respect for the writer as a published author and may lead to an invitation to help develop new reporting guidelines. ³

Proper use of guidelines can increase writers' professionalism and authors' perception of their professionalism. ⁴ A writer using the CONSORT checklist should cite it. ⁵

Use in regulatory writing

Manuscript guidelines can help improve, simplify and speed regulatory writing, including work restricted to ICH E3 documents for health authorities. ^{6, 7}