| Effective medical writing is the key to successful | | | | - Challenge: The clinical submission will require a team |
| clinical submissions. Medical writing should be effective | | | | effort between writers, QC (Quality Control), QA |
| in terms of cost, time and effort. Other | | | | (Quality Assurance), sponsor functions, experts, |
| characteristics of effective medical writing for | | | | CROs (Contract Research Organizations), etc., "what |
| regulatory submission include quality-controlled, | | | | is the process for file and information transfer |
| quality-assured, consistent, accurate, version correct, | | | | between team members onsite and offsite, in-house |
| data-driven, GCP-driven, process and procedure | | | | and remote"? Solution: Develop a process and |
| adherent. In order to maximize the potential for a | | | | procedure and adhere to that process and procedure |
| positive regulatory filing with the FDA or similar | | | | throughout the clinical submission. Communicate the |
| regulatory bodies in countries outside the US, medical | | | | process and procedure to all team members at the |
| writing for clinical submission should planned and | | | | beginning to obtain team commitment to follow while |
| managed to the characteristics early in the | | | | informing of the consequences for deviating from.For |
| development of a document to be written. | | | | effective medical writing for clinical submission, these |
| Consider all documents and components, for | | | | are important points to consider early in the process. |
| example, appendices, and narratives, tables listings, | | | | Once the submission team establishes a TOC with |
| figures and graphs required for a regulatory | | | | the FDA or relevant regulatory submission body for |
| submission, the following experienced based guidance | | | | the clinical filing, responsibilities and accountabilities are |
| is intended to simplify the process: | | | | assigned to individual medical writers. Common |
| - Challenge: The regulatory submission for a drug for | | | | questions that arise include: "Who will write which |
| example has 5 CTD (Common Technical Document) | | | | documents? Will the documents be written by the |
| Modules, "what documents and document | | | | sponsor? Will the documents be written by the |
| components are to be written"? Solution: Develop a | | | | pharmaceutical functional areas? Will the documents |
| TOC (Table of Contents). | | | | be written by the CRO or will the documents be |
| - Challenge: The regulatory submission will require a | | | | written by consultants, members of a high level |
| format, "what format will be followed"? CTD? Legacy | | | | medical writing project/clinical submission team asked |
| NDA? 505 (b)(1) or (2)? Solution: Choose a format. | | | | to participate (outsourced) by the sponsoring |
| - Challenge: The clinical submission will require source | | | | pharmaceutical company?" |
| documents to support the written documents, "what | | | | These and other questions will be addressed in the |
| are the source documents, which will be included in | | | | Dante Resources Effective Medical Writing article |
| the clinical submission"? Solution: Develop a TOC that | | | | series. |
| reaches this level of granularity! | | | | |