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1. globalhealthtrials.tghn.org › articles › downloadable-templates-and-tools-clinicalDownloadable Templates and Tools for Clinical Research

   globalhealthtrials.tghn.org › articles › downloadable-templates-and-tools-clinical

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   Welcome to Global Health Trials' tools and templates library. Please note that this page has been updated for 2015 following a quality check and review of the templates, and many new ones have been added. Please click on the orange text to download each template.

   • 5 Ways Statistics Can Fool you—Tips for Practicing Clinicians

     Good Clinical Trials Prism; Hub Impact; About This Site; 26...

   • Webinar on Community Engagement in Clinical Research Involving Pregnant Women

     The Global Health Network recorded a webinar on the value of...

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     Not a member? Find out what The Global Health Network can do...

   • Data Management and Statistics

     A recently published paper in PLOS Medicine has investigated...

   • Resources

     Global Health Trials contains numerous Peer-Reviewed...

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   • Trial Management

     The last decade has witnessed a substantial increase of...

   • Monitoring

     A set of 4 consent templates for clinical trials, interview...

2. www.nia.nih.gov › research › clinical-research-study-investigators-toolboxClinical Research Study Investigator’s Toolbox

   www.nia.nih.gov › research › clinical-research-study-investigators-toolbox

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   Investigators submitting grant applications for clinical trials are required to include a general description of the DSMP as part of the research grant application. For behavioral and social clinical trials, consider using the adapted DSMP Template (MS Word, 62K).

3. www.nejm.org › doi › fullTrial Reporting in ClinicalTrials.gov — The Final Rule

   www.nejm.org › doi › full

   17 lis 2016 · The FDAAA established legal requirements for sponsors and designated principal investigators (i.e., responsible parties) to report specified clinical trial information for certain applicable...

4. ec.europa.eu › h2020 › otherTemplate for essential information to be provided for proposals...

   ec.europa.eu › h2020 › other

   1 A ‘clinical study’ is defined for the purpose of this template as any clinical research involving a substantial amount of work related to the observation of, data collection from, or diagnostic or therapeutic intervention on multiple or individual patients.

5. www.ema.europa.eu › en › ich-e3-structure-content-clinical-study-reportsICH E3 Structure and content of clinical study reports -...

   www.ema.europa.eu › en › ich-e3-structure-content-clinical-study-reports

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   This document aims to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. Read together with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline E3: Questions and answers (R1) .

6. www.clinvigilant.com › basics-of-case-report-form-designing-in-clinical-researchBasics of Case Report form Designing in Clinical Research -...

   www.clinvigilant.com › basics-of-case-report-form-designing-in-clinical-research

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   Standard Case Report Form Templates. Standard CRF templates provide consistent structure. However, specific measurement parameters and instrument selection should align to study aims. Commonly used templates include: Medical history; Concomitant medications; Adverse event reporting; Vital signs; Laboratory assessments; Patient-reported ...

7. clinicalstudytemplates.com › 01 › template-clinical-study-report-pdf-sample-8Clinical Study Report (CSR) Template

   clinicalstudytemplates.com › 01 › template-clinical-study-report-pdf-sample-8

   This Clinical Study Report (CSR) Template is specifically designed to be used in conjunction with the Clinical Study Protocol (CSP) Template. The structure and sections as well as their order and content follow the International Council for Harmonisation (ICH) E3 guidelines for CSRs, as recommended by the Food and Drug Administration (FDA).