Contract medical writers sometimes find themselves hired to write a clinical study report (CSR) (or clinical trial report (CTR)) before their client has prepared all of the information needed for the report.Stacks of cash This leads to frustration and causes delays in the CSR 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 very painful result of delayed CSR preparation is the sponsor’s loss of considerable revenue for every day that the marketing application’s approval is delayed.

Clearly, writing the CSR promptly, at least on study completion, is the wise course of action. Doing this can reduce the cost of generating the CSR, compared with writing the CSR months or even years after the study is closed. And 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, 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 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 documents are available only as hard copies, they should be scanned for incorporation into the CSR. If the writer only receives hard copies of the documents they need to work with, the cost of the CSR will be much higher than if electronic copies are provided. This is because the writer will have to scan the hard copies to convert them into electronic files in order to incorporate them into the CSR, which is time consuming.

Although PDF-formatted files will be somewhat helpful in drafting the final report, the medical writer really needs the protocol, any amendments, and 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 may have to type the information into the draft CSR, possibly introducing errors and requiring more time to incorporate the protocol text into the report.

When should the writer begin developing a CSR? Ideally, the CSR should be developed in parallel with the clinical study protocol. Although this doesn’t often happen in the real world, the CSR template certainly can be populated with information from the protocol long before study completion and database lock. Then, when the SAS data are available, the rest of the CSR can be completed relatively quickly. This approach saves a great deal of time when compared with waiting until database lock to begin writing the CSR!

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 (AE) and/or serious adverse event (SAE) narrative template, if applicable (ie, if there were AEs and/or SAEs reported in the clinical study, and if those events will be written as narratives for inclusion in the CSR)
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; name, title, and contact information for Principal Investigator who will sign the 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

File folders as content1.   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 case report forms (CRFs)
8.   Safety (AE and/or SAE) narratives, if applicable
9.   Statistical Analysis Plan (SAP; sometimes called the Data Analysis Plan, or DAP), 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 (strongly preferred as Microsoft Word files)
17. Investigator brochure (versions used in the study, preferably as Microsoft Word files)
18. Chairperson and address of DMC/Steering Committee, if applicable
19. List of site names, numbers, and locations
20. Name of the company that managed the clinical trial supply
21. Names and addresses of laboratory facilities used
22. Laboratory certificates and normal ranges for all laboratories
23. Investigators’ CVs (as PDFs or scans)
24. List of investigational drug batch numbers and list of subjects (by subject number) receiving each batch of investigational drug (Note: This is often the hardest information to acquire for the CSR.)
25. List of protocol violations and/or deviations (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 in this post isn’t intended to be definitive. Each individual clinical study may require documents that I haven’t mentioned here; conversely, some studies won’t require some of the document types that I’ve listed. Consult the relevant regulatory guidelines to verify the kinds of documents required for preparing your ICH-compliant CSR.

Copyright 2009-2016  Biotech Ink, LLC.  All rights reserved.

62 responses »

  1. rethoryke says:

    Very helpful!

  2. Glad this is a useful list. Keep in mind that it isn’t meant to be comprehensive, and the report content will depend somewhat on the type of report (eg, interim, abbreviated, or full length). If you find errors or omissions that should be included, please do share them with me!

  3. Shalini says:

    This is a great write up. Thanks for providing us with such a comprehensive list, Susan.

  4. Soo says:

    Thanks for the info. Just what I needed as I am working on my first CSR project.

  5. Keep in mind it isn’t a comprehensive list, just a general guide. Good luck with your CSR–they can be challenging projects.

  6. Bob says:

    What is the best way to get started as a freelance medical writer?

    • Robert,

      It depends on your background and the type of medical writing you want to do. If you want to write regulatory documents for drugs and/or medical device development and you have worked in the pharmaceutical, biotech, and/or medical device industries, it may be a fairly easy transition. If you don’t have that experience, there are still things you can do to position yourself for such a career. There are also other types of medical writing, including manuscripts, marketing, and medical journalism, and the preparation for these careers is somewhat different. I can elaborate after you let me know what kind of medical writing you want to do, and what your background is.

      Regards,

      Susan

      • sakshi shrivastava says:

        Hi Susan,

        I have worked as a medical writer in pharma and KPO sector(written manuscripts, monographs, narratives etc) for 6 years now. However, now I am on a family way and want to start freelancing instead of a full time job. Could you guide me on how to get started with freelancing, which sites to go to etc?

        Thanks,
        Sakshi

        • Sakshi,

          Please see some of the articles here on my blog–they are something of a guide to what is needed as a medical writer, and also as a consultant/contractor. In particular, I suggest you read the one about cash flow, which can be a real killer to a freelancer. There are other medical writing blogs and articles online, too, that can shed additional light on the good and bad aspects of freelance medical writing.

          Best wishes as you develop your career path!

          Susan

  7. Cathy says:

    Hi Susan- this is a great blog! Thanks for devoting the time to it! It appears that Bob hasn’t replied but I have the same question about how to break into the field. I am switching career tracks from an academic research/faculty position and hope to get a position as a writer with a CRO or pharma company. I have a lot of experience writing grant proposals and research articles but very little clinical writing experience. I have joined AMWA and I’m currently enrolled in a certificate program. But all the jobs I see require experience that I don’t have. Any suggestions would be greatly appreciated! Cathy

    • Cathy,

      My best suggestion is to get clinical research experience in a biopharmaceutical or medical device environment. You have to understand the way drugs/medical devices are developed before you can competently write the documents that support their development. A few years of work in the industry will help prepare you for a medical writing career if combined with excellent writing skills and a strong understanding of medical terminology.

      Best regards,

      Susan

  8. Maneesh Misra says:

    Hi Susan,

    I have been working in Medical Devices & Diagnostics.

    How do you advice me for freelance medical writing as a career & how to get started.

    Regards

    Maneesh

    • Maneesh,

      My suggestions are to learn as much as possible about medical terminology, get experience in the biotech/pharmaceutical and/or medical device industries (particularly in clinical research), and posses highly developed writing skills. These three approaches should help you get started in a medical writing career.

      Regards,

      Susan

  9. Sandhya says:

    Thank you for this comprehensive list Susan; it has been very helpful.

  10. […] Before attempting to assemble a CSR, it is helpful to go through a checklist of items needed to prepare this document.  Susan Caldwell on her blog Biotech Ink Blot lists 48 pieces of information that should be available to a medical writer to complete the task. […]

  11. Paula T. says:

    I am a pharmacist and I want to get into the medical writing field. My experience is in retail pharmacy and I have no medical writing experience.
    The job that I am looking for lists these requirements:

    Manage medical writing projects according to SOPs and client standards, on-time and on-budget
    Prepare Clinical Study Reports (CSRs), protocols, abstracts, and summary documents for regulatory applications, and other regulatory documents
    Perform quality control review of medical writing documents
    Assist in developing strategies for organizing and preparing regulatory documents

    Can you please recommend what courses to take to prepare to meet the requirements for this job?

    Thank you so much!
    Paula T. Pharm.D.

  12. Rudresh says:

    Thanks a lot Susan; it does really help me in drafting CSR!!!!!!!!!!!!!

  13. Lori says:

    Susan, can you provide any recommendation for how to find a contract medical writer with experience specifically in writing technical documents such as CSRs and efficacy/safety summaries?

    • Lori,

      The internet is full of resources that help you find regulatory medical writers (ie, medical writers who develop clinical study protocols, amendments, clinical study reports, investigator brochures, NDAs, INDs, and BLAs), including the various search engines, job postings through AMWA (www.amwa.org) and DIA (www.diahome.org), and job postings on http://www.biospace.com, http://www.monster.com, and other job boards.

      Hope this helps,

      Susan

  14. Kamlesh Israni says:

    Dear Susan,
    Reading your reply to Robert, I want to thank you for that kind and informational reply.
    I too want to go for same – Freelance Medical Writing and I have got 5yrs exp. in biotech (basic research) after my Bachelor’s degree in Chemistry, now going through Clinical Research studies (theoretical part and nothing on practical grounds). Just wanted to know which particular medical writing will be much helpful for me – keeping in mind I don’t have any experience in writing.
    Also please let me know are there any particular courses (online courses) or books available for which can help to a starter like me.
    Waiting for your kind reply.
    Thanks and Regards,
    Kamlesh Israni

    • Kamlesh,

      Getting the clinical research experience will be enormously helpful to you in starting a medical writing career. In addition, you should ensure that your English language skills are top notch, and that you have an in-depth familiarity with the ICH guidelines. If you wish to take courses, there are numerous excellent offerings through AMWA (www.amwa.org) and DIA (www.diahome.org).

      Hope this helps,

      Susan

  15. Catherine Wightwick says:

    Useful list – thank you!

  16. pam says:

    hello susan,
    can you please advise me as to the best way to document an ongoing subject pregnancy in a CSR- ?
    Thanks so much for your help !

  17. Alpesh Ramani says:

    It is very much informative and remarkably written extract of Medical writing experience.

  18. Pat French says:

    Just found this list, via the AMWA Editing-Writing listserv. What a wonderful resource–thanks for compiling it!

  19. Dr. Ruma Dewan says:

    In my experience, I have also ended up explaining to the client about what stats were required as they did not fit into the report; when I was assigned the task (!)

  20. Pratik says:

    Hello..
    I am very much glad to get such an important and useful information for preparation of CSR.
    I am using this information to prepare my first CSR because of the simplicity and elegance of this above furnished information.

    I would like to know about in detail of some points and documents enlisted here during my preparation of CSR .

    Thanks a lot.!
    Regards,

    Pratik.

    • Pratik,

      I’m pleased that this information can help you in developing your first CSR. Although I haven’t posted much in the way of details about these various items, I’d be happy to address them for you if you have a few questions.

      Regards,

      Susan

  21. Gloria says:

    Hi Susan ,

    Would you be able to categorize the common errors we find while QC;ing or reviewing a CSR before finalizing it.

    • Gloria,

      Some errors are related to conformance of the CSR’s headings and Table of Contents (TOC) with the ICH E3 outline for CSRs. Other errors are about whether the content really fits its E3 section heading, whether the content is complete (including appendices), and whether the content across sections is consistent and mutually supportive. There are other consistency errors, such as matching the data in the text with in-text tables, and matching the data between the in-text table and the SAS output (which should usually be a copy-paste job, so that no data consistency issues arise). Reference errors often crop up, in which the citation is wrong, or the cited reference doesn’t truly support the statement being made in the CSR. There are formatting errors, spelling, grammatical, capitalization, and many other types of errors. This just touches on the types of errors that are common in CSRs. If I made a comprehensive list, it would be very, very long!

      Hope this helps,

      Susan

  22. VD says:

    Dear Susan,

    This is indeed a very useful write up on CSRs. Much appreciated!

    Would it be possible for you to share similar write up for IBs, DSURs and Protocols? Alternatively, it would be great to know the source, if similar write up already exists on internet.

    Regards,

    VD

    • VD,

      Thanks so much–I’m glad you find the article useful. At some point I would like to write up a similar list for IBs and other regulatory documents, but at present I don’t have the bandwidth to do it. Great idea, though.

      Regards,

      Susan

  23. David Gordon says:

    Dear Susan, I’m in the process of reviewing procedures for research project initiation through to completion and wondered if you had developed or could recommend any neat file naming conventions for standardising the way in which researchers store the myriad of files developed in a research project?

    • David,

      Generally what I do is to include in the filename the date (always in the DDMONYYYY format, eg, 04Feb2013), the topic of the document, and any details that make it unusual (such as Draft 3, FinalforApproval, etc). Over the last 8.5 years as a medical writer consultant, I haven’t developed just one standard naming convention, because each client’s needs and their own conventions have differed. Wish I could give you more guidance than that, but it is a sloppy business to name files, unless the organization has a written rule for how files are named.

      Hope this helps,

      Susan

  24. Nanda Gopal says:

    Hey Susan,

    Thanks a ton for the information presented in such a systematic way. I have written CSRs and am into free lancing now. Your list serves well as a ‘to do’ and takes out the headache of getting into bottlenecks during the writing process.

    Nanda.

    • Nanda,

      I made the list because clients sometimes hired me to do CSRs without having all their informational ducks in a row. Thought it might help MWs and sponsor companies alike get organized for these challenging writing projects.

      Best regards and happy writing,

      Susan

  25. MK says:

    Dear Susan,

    Thanks for the excellent rendition on CSR! It helps MWs trim the text and fill in any information left to deliver a diligent report any level.

  26. Judy says:

    Where can I find guidelines (or a template) specific for an interim CSR?

  27. Judy,

    I’ve always used an existing template for final CSRs, modified appropriately for the content of the interim report. It should be ICH E3-compliant, and searching through E3 (ich.org, Efficacy Guidelines; E3 is a downloadable PDF) will show you areas of the CSR that should address interim analyses.

    Hope this helps.

    Best regards,

    Susan

  28. This page really has all the information and facts I wanted concerning this subject and
    didn’t know who to ask.

  29. MM says:

    Hi Susan,

    Good read. I have a quick question for you. Would I place a PK report in Appendix 16.1.9?

    • Mayra,

      Thanks. I’ve seen PK reports done a couple of ways. In many cases, companies publish the PK report in the Appendix of the CSR, creating a special subsection in section 16 for that purpose. Section 16.1.9 is the stats method section, so I wouldn’t put it there. However, you could create a 16.1.13, and make it the PK Report section. This would avoid changing the subsection numbering downstream from the PK report, since the numbering jumps 16.1.12 to 16.2.

      Alternatively, some companies publish the PK reports separately from the CSR, but include it in a package with the CSR, as appropriate.

      Susan

  30. Luis Acosta says:

    Great article Susan. So helpfull for early task discussions with clients.

    Luis

  31. Phil Davies says:

    Hi Susan,

    I am a contract technical Author within the Pharmaceutical Industry. I would like to get into Medical writing. Any advice on how to start ??

    Regards,
    Phil

    • Hi, Phil,

      Sorry, but I can’t answer your question without knowing a bit more about your background and experience. Read my blog and those of other medical writers to get a better idea of what’s required and whether you have those qualities. In particular, please read my article, “What It Takes to Be a Medical Writer”–it addresses many of the traits that successful medical writers have.

      Best regards,

      Susan

  32. Dr. Anagha Parkhi says:

    hi Susan,
    I would like to know that while working in any organization, does one person writes all the sections of the CSR?

    • It’s rare for the medical writer to write all of a clinical study report (CSR). Typically, there is a team that writes a CSR, usually with a biostatistician, the medical monitor, clinical operations personnel, administrative support, and the medical writer. The reason for this is that it’s almost impossible for one person to have all the knowledge and information that is needed to write a credible CSR. A team collaborates to write it together, providing ongoing feedback to the medical writer, who pulls all the written contributions together and gives them one voice and a defined style that’s compatible with other related documents.

      Best,

      Susan

  33. Tracey says:

    Hi Susan,

    Just what I needed! I am interested to transitioning into medical writing from the Pharmacovigilance (PV) arena and am appreciate all of the information that I can find. I am taking full advantage of the educational opportunities provided by the American Medical Writers Association (AMWA) and am taking workshops as I can afford them. While my experience in PV has provided me the opportunity to develop safety narratives for clinical and post-marketing (drug/biologic/device), I fear that it will not be enough to support my transition.

  34. I’ve been a medical writer and medical monitor in industry for more years that I like to admit. I think your list is very helpful. It’s important to identify and start collecting the details early so the approval of the final report is not delayed. Sometimes, it’s difficult to track down the person who can supply each bit of information especially if companies have been acquired or if staff or CROs have come and gone.

    • Totally agree with you. I recommend starting the appendix-gathering process during Draft 1 or at least Draft 2 review. Otherwise there may be ugly surprises downstream. In some cases, it may take months to acquire all of the needed information.

      Thanks,

      Susan

  35. persis says:

    hi Susan very useful info, neatly written .i have years of clinical data capturing experience ,worked as CDM i have publications in signalling pathways with my bench work experience ,I have doctorate degree but never written CSR! the job i am going to interview is asking preparing of clinical trial reports, PSUR/DSUR , roll over studies , procedure manuals drafting summaries ,
    do you have written blogs with these info too? any suggestions you have for me?

    • Persis,

      No, I haven’t written any blog material on PSURs, safety, etc. However, one of the articles on my blog lists the items that the writer needs to do a clinical study report.

      My blog isn’t intended to tell medical writers how to do their job–this is something that is learned hands-on in the industry and with clients when consulting.

      You don’t say what your doctorate degree is in–if it’s in a life science, this provides a very sound basis for a medical writing career. Suggest you get some direct industry experience in drug development, and you will be well positioned to transition into medical writing.

      Best regards,

      Susan

  36. Claire says:

    What information should be included in a final CSR when the study had an interim report? Also, should the interim report be referenced in the final CSR?

    I love the content! It has been very helpful.

    • Hi, Claire,

      I recommend making the final CSR comprehensive–provide all of the information you ordinarily would, even if there was an interim report. After all, some readers may not have access to the interim report, so the final CSR should be complete. And I would definitely reference the interim report in the final CSR; some readers may want to go back and look at the data that were available at the time the interim was written.

      Hope this helps,

      Susan

  37. Claire says:

    Thank you, Susan! Very helpful.

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