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| 31 July 2009 Published weekly by Biotech Ink, LLC |
Vol 2 No 22 | |
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48 Things Medical Writers Need for Clinical Study Reports
by Susan E Caldwell, PhD, Managing Editor, Biotech Ink Insider |
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Contract medical writers sometimes find themselves hired to write a clinical study report (CSR) (or clinical trial report (CTR)) before the sponsor has prepared all of the information needed for the report. This leads to frustration and causes delays in the CSR's development. In turn, delayed CSR completion can extend the actual submission date of the product's eCTD/marketing application, because CSRs are required content. Thus, the painful result of delayed CSR preparation is the sponsor's loss of considerable revenue for every day the marketing application's approval is delayed.
Clearly, writing the CSR promptly, on study completion, is the wise course of  action. Doing so can cut the considerable cost of generating the CSR when compared with writing the CSR months or even years after the study is over. One of the most effective things the sponsor can do to prepare for prompt CSR completion is to have the items listed below available when the medical writer begins drafting the CSR.
The items in this list include some documents and tools that must be available for CSR completion. However, this list isn't meant to be comprehensive, and some items are optional. Other items are needed only in specific circumstances, such as when specific clinical trial designs are used. This checklist applies to full-length CSRs that document the execution and completion of clinical studies of drug and biologic investigational products.
 All of the documents listed here should be provided to the medical writer in electronic format, assuming the CSR will eventually be included in an electronic regulatory submission. If the needed documents are available only as faxes or hard copy, those documents should be scanned and converted to PDF format for incorporation into the CSR.  Although PDF-formatted files will be somewhat helpful in drafting the final report, the medical writer really needs for the protocol, its amendments, and the investigator brochure files to be in Microsoft Word format. This is because the writer must copy and paste into the CSR specific, verbatim language taken from these documents, especially the protocol. Without a Word file, the writer will have to type blocks of text into the draft CSR. This may introduce errors, requires more time, and inflates the cost of incorporating the text into the report. The documents that medical writers need to produce a fully ICH-compliant CSR are provided below in two categories: Tools and Administrative Information and Content.
Tools and Administrative Information
1. Protocol number or study number
2. Study number in ClinicalTrials.gov
3. Number and name of each clinical study site or center
4. Sponsor's in-house style guide, if applicable, and published style guide, if applicable (eg, AMA Manual of Style, 10th Edition)
5. Clinical study report template in Microsoft Word, if available
6. Adverse event and/or serious adverse event (SAE) narrative template, if applicable
7. Clinical study report project timeline
8. For interim reports, the cutoff date for clinical study data to be presented in the interim report
9. Name, title, and contact information for sponsor's representative who will approve and sign CSR
10. Description of naming conventions for clinical study report files, if applicable
11. Names and contact information of sponsor personnel with whom the writer will work to draft the CSR
12. Information on how to store, archive, and circulate draft and final CSR, if applicable
13. Directions as to who will store, archive, and circulate draft and final CSR
14. Decision from the sponsor as to which investigational product name will be used consistently in the CSR, if applicable (especially if the product name has undergone changes since protocol was written)
15. Names and addresses of CROs used and description of their role in the study, if applicable
16. Sponsor's content- or process-related SOPs that apply to writing clinical study reports
17. Description of sponsor's ideal label for the investigational drug product (optional)
18. Clinical development plan (optional)
19. ICH Guideline E3, The Structure and Content of Clinical Study Reports
20. FDA Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications, if applicable
21. European Medicines Agency (EMEA) - Note for Guidance on the Inclusion of Appendices to Clinical Study Reports in Marketing Authorisation Applications, if applicable
Content
1. Clinical data as tables, listings, and figures (TLFs)
2. Screening logs for subject disposition (if not provided in TLFs)
3. Case report forms (CRFs) of subjects who had serious adverse events (SAEs)
4. Milestone study period dates: dates when first subject enrolled, last subject enrolled, and last subject completed study
5. List of IRBs/IECs/DMC addresses and chairperson's name
6. Sample study-specific master Informed Consent Forms for protocol and all amendments
7. Study-specific CRFs
8. Safety narratives, if applicable
9. Statistical Analysis Plan (SAP), if applicable
10. Pharmacokinetics (PK) report, if applicable
11. Pharmacodynamic report, if applicable
12. Toxicology report, if applicable
13. Immunogenicity report, if applicable
14. List of references (abstracts or manuscripts) from publications derived from clinical study data
15. PDF files of all medical literature supporting the study and cited in the CSR
16. Original clinical study protocol and all amendments (preferably as Microsoft Word files)
17. Investigator brochure (version(s) used in the study, preferably as Microsoft Word file(s))
18. Chairperson and address of DMC/Steering Committee, if applicable
19. List of site names, numbers, and locations
20. Name of the company who managed clinical trial supply
21. Names and addresses of laboratory facilities used
22. Laboratory certificates and normal ranges for all laboratories
23. Investigators' resumes or CVs
24. List of investigational drug batch numbers and list of subjects (by subject number) receiving each batch of investigational drug
25. List of protocol violations (if not included in TLFs)
26. List of investigators and study personnel, mailing and e-mail addresses, telephone and fax numbers; if lead principal investigator, identify and include contact information
27. List of names and contact information of sponsor's personnel who participated in the clinical study: medical monitor (usually an MD), biostatistician, and clinical research associate(s)
This list is a reflection of my experience directing medical writing departments and doing medical writing since 1995. The information shown here isn't intended to be definitive or comprehensive. Each individual clinical study may require unique documents that I haven't mentioned here; conversely, some studies won't require some of the document types that I've listed. Please consult the relevant regulatory guidelines to verify the kinds of documents required for preparing your ICH-compliant CSR.
Copyright 2009 Biotech Ink, LLC. All rights reserved.
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Open Jobs and Gigs for Medical Writers
The jobs listed in the Biotech Ink Insider come to us mostly by word-of-mouth and direct contact with hiring managers and recruiters. If no new jobs are communicated to us in a given week, the Insider won't be published that week. See also our disclaimer at the bottom of the newsletter.
If you're a writer or editor and are getting calls about staff or contract positions you aren't interested in, please forward that job information to Susan Caldwell at caldwell@biotechink.com. We'd be delighted to publish such positions in the next issue of the Insider. |
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Principal Medical Writer
Union, New Jersey |
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6-month contract, W-2, no benefits, on site; job ID 4004
Position Overview
Will be responsible for the preparation of clinical documents for worldwide sub-missions to regulatory authorities and for leading medical writing teams assembled to support large projects. Will support Managers within Medical Communications by providing technical guidance to junior members of the department.
Responsibilities
- Independent preparation of clinical study reports, integrated clinical summaries, overviews, and other regulatory documents on investigational drugs in various stages of clinical development.
- Lead medical writing teams assembled for large projects, e.g. submissions; coordinate and direct work of internal or external medical writers assigned to the writing team.
- In conjunction with Director and MedCom Managers, will coordinate resource allocation and identify projects that exceed capacity of internal Medical Writing staff.
- Will serve as liaison between outside writing sources and will review documents prepared by those outside resources.
- Will serve as department's representative for assigned therapy team/working groups; and will participate in determining submission-level timelines.
- Will review, update and communicate the operational and functional procedures utilized by the department with regard to document creation, review, quality control and publishing/archiving.
- Will also serve as a technical expert for the department and represent the department in cross-functional decision making teams and committees.
Requirements
- An advanced degree in Life Sciences - PhD or PharmD preferred (ideally, university doctorate/PhD)
- 10-plus years in Pharmaceutical Research & Development, with at least 5 of those years in Senior-Level Medical Writing.
- Ideally, 5+ years industry experience
Compensation
$50 to $60 per hour
Contact
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