Resources for Medical Writers

Regulatory Medical Writing

Note on use of Regulatory Medical Writing Section

List of generally useful links  

Brief survey of freelancers on the topic of registration documents.

Adaptive Study Design

EMA reflection paper, 2007

FDA draft guidance, 2010 

Clinical Study Report (CSR) and Abbreviated CSR

Abbreviated CSRs of Investigational Medicinal Products for human use: Current guidelines and recommendations

ICH E3: Structure and content of CSRs, Final Concept Paper

ICH E3: Structure and content of CSRs

Note for guidance on coordinating investigator signature of CSRs

Note for guidance on the inclusion of appendices to CSR in Marketing Authorisation Applications

Submission of abbreviated reports and synopses in support of Marketing Authorisation Applications

E3 Implementation Working Group ICH E3 Guideline: Structure and Content of Clinical Study Reports Questions & Answers (R1)

Common Technical Document (CTD)

Centralised procedure for Marketing Authorisation Application

CTD: Non-clinical overview and summaries

ICH guideline M4:Organisation of the CTD

ICH guideline M4: Q & A

ICH guideline M4E: Clinical overview and clinical summary

ICH guideline M4E:Q & A

ICH Safety guideline M4S: Q & A 

ICH Quality guideline M4Q: Overall summary

ICH Quality guideline M4Q: Q & A

Notice to applicants: Presentation and format of the dossier CTD

Q&A: Presentation and content of the dossier CTD, 2003 Edition

Definition of Products and Study Types

Clinical trial algorithm

Guidance on IMPS and NIMPS

Development Safety Update Report (DSUR)

ICH E2F Guidance on DSUR

FDA-specific

Adaptive study design draft guidance, 2010 

FAQs: Statement of investigator form

Integrated summary of effectiveness

Location of integrated summaries within the CTD

Patient-reported outcome measures

ICH E3 Implementation Working Group: Q&As R1 January 2013

Good Clinical Practice (GCP)

European Commission clinical trials directive

European Union directive

ICH GCP guideline E6(R1)

UK regulations on clinical trials

Investigational Medicinal Product Dossier 

EC guidance

Investigator's Brochure 

EU guidance on CTA

IB Regulatory Questions and Answers

ICH guideline for GCP, E6(R1)

Investigator's Brochure

Medical Devices

European Commission guidance document

European Commission guidelines on clinical investigations for medical devices

European Commission guidance on interpretation of directive

ISO guidelines for reporting clinical studies on devices

Observational Studies

Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies

Clinical trial algorithm: interventional or observational trial?

Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies

Paediatric Studies

Clinical and Operational Challenges in Paediatric Clinical Trials May 2012

EMA FAQs

EMA guideline for role of pharmacokinetics

Ethical considerations

EU Paediatric Legislation and Challenges May 2012

EU PIP guideline, 2008

ICH guideline E11

Suggested reading for Paediatric Investigation Plan (PIP)

Periodic Safety Update Report

Periodic Benefit-Risk Evaluation Report: guideline May 2012

PSUR: guideline June 2012

Protocol and Protocol Amendment

Declaration of Helsinki

EC guidance on CTA application

ICH guidelines for GCP and Investigator's Brochure

Report Risk Management

EMA guidelines

Selected Scientific and Therapeutic Area Guidelines 

EMA guidelines for evaluation of anti-infectives

ICH guideline for non-antiarrhythmic drugs (E14)

Statistics

ICH guidance on statistical principles for clinial trials (E9)

Summary of Product Characteristics (SmPC)

EC guideline on SmPC

SmPC template

Medical Communications & Publications

Software

General

Books (Introduction to Systematic Reviews)

 

Document templates for MWs

Cosmetic regulatory writing

EMWA guidelines for authoring peer reviewed publications (Jacobs and Wager 2005)

ICMJE guidelines

In the book stores (Mastering Scientific and Medical a self help guide)

In the book stores (Statistics, Epidemiology, MS Word 2010 for MWs)

Medical Statistics Made Easy 2 (book review)

MW competencies vs job adverts (Heisel Stoehr and Schindler)

Pesticide dossiers, an opportunity for MWs


QC (Nicola Haycock)

REACH dossier

Veterinary regulatory writing in Europe

What editors want (in the bookstores)

A recipe for chaos: Medical writing, time management, and cooking for friends (Wendy Kingdom. TWS 2008;17(3).)


Broad-spectrum medical writer: Nature or nurture? (Alison McIntosh. TWS 2009;18(1).)

Ergonomics and the medical writer (Alice Knight; TWS 2010;19(4).)

Freelance or employee: Which is better? (Phillip Leventhal. TWS 2009;18(2).)


Have you ever met a statistician and wondered how they got that way? (Peter Wilkinson. TWS 2009;18(3).)
 

Reading round your therapeutic area (Alison McIntosh. TWS 2007;16(2).)


Saving a brain drain: The Norwegian-Russian Centre for Medical Studies and a medical writer's role in grant applications (Kari Skinningsrud. TWS 2007;16(2).)

The art of time management (Joeyn Flauaus. TWS 2008;17(3).)


The 'fuzzy logic' of the European medical device world: Interview with an expert (Claudia Frumento. TWS 2010;19(2).)

Time management—Who manages your time? (Alistair Reeves. TWS 2008;17(3).)

Getting more time out of your day (Debbie Jordan. TWS 2008;17(3).)

When time is wide open and deadlines do not press (Jack Aslanian. TWS 2008;17(3).)

 

Useful Links

General reporting requirements for publishing clinical studies

Uniform Requirements for Manuscripts Submitted to Biomedical Journals

http://www.icmje.org/icmje-recommendations.pdf

Consolidated Standards of Reporting Trials (CONSORT) guidelines

http://www.consort-statement.org

CORE Reference

http://www.core-reference.org/

Equator network (includes all the publishing guidelines STROBE, CONSORT etc.)

http://www.equator-network.org/

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Evidence-based minimum set of items for reporting systematic reviews and meta-analyses.

http://www.prisma-statement.org/

Strengthening Reporting of Observational studies in Epidemiology (STROBE)

http://www.strobe-statement.org/index.php?id=available-checklists

Conflict of Interest form

http://icmje.org/conflicts-of-interest/

Language and style

Style in general

http://www.amamanualofstyle.com/

Citations

http://www.johnsquirelibrary.org.uk/guides/referencing.htm

http://www2.le.ac.uk/library/help/citing/

Abbreviations journals

http://home.ncifcrf.gov/research/bja/

Phrase database

(especially useful for not-native English speakers)

http://www.phrasebank.manchester.ac.uk/

Language editing

http://webshop.elsevier.com/languageservices/languageediting/pages/pricing_eur.html

Illustration services

http://webshop.elsevier.com/illustrationservices/

Grammar and plagiarism check

http://www.paperrater.com/

Proofreading software

http://www.intelligentediting.com/default.aspx

Free online checker with limited features:

https://www.intelligentediting.com/onlinechecker/default.aspx

Conversion calculator

http://www.amamanualofstyle.com/page/si-conversion-calculator

Translator

https://translate.google.com/

Online vocabulary

http://dict.leo.org/

Medical background

Medical acronyms and abbreviations

Medical dictionary

Drugs Search

http://www.medilexicon.com/index.php

Medical dictionary

http://medical-dictionary.thefreedictionary.com/

Statistics

Statistical analysis for offline use

http://www.openepi.com/v37/Menu/OE_Menu.htm

Online Statistical analysis tools

http://statpages.org/

Software

Free reference manager

http://www.mendeley.com/

https://www.zotero.org/

Free time tracker

http://www.freshbooks.com/

Miscellaneous

Literature search database

(Advantage of DIMDI: databases can be pre-selected)

http://www.ncbi.nlm.nih.gov/pubmed

http://www.dimdi.de/dynamic/en/db/recherche/index.htm

Maude database

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

Impact factor

http://impactfactor.weebly.com/

Search tools

www.wikihow.com/

http://scholar.google.com/

Implement screenshots for artwork

http://www.techsmith.com/

File transfer

https://www.dropbox.com/

Unlock pdf

http://freemypdf.com/


Please visit the Freelance Resource Centre here.