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.

 

The templates below have been shared by other groups, and are free to use and adapt for your researchstudies. Please ensure that you read and adapt them carefully for your own setting, and that you reference Global Health Trials and The Global Health Network when you use them. To share your own templates and SOPs, or comment on these, please email info@globalhealthtrials.org. We look forward to hearing from you!

 

These templates and tools are ordered by category, so please scroll down to find what you need.

Category Tool or Template SOPs
General Logs and Trackers

Telephone contact log

Generic SOP template

Meeting Minutes Template

Management of SOPs SOP

Regional Meeting Budget Template with Example Data

Identifying Critical Suppliers SOP

 

Preparing SOPs SOP

Developing protocol

Concept protocol – template

Risk Assessment for Trial SOP

Protocol feasibility checklist

Protocol feasibility assessment SOP

Risk assessment template

Protocol Amendments Assessment SOP

 

Investigator brochure or IMP dossier development SOP

Disseminating findings

Clinical study report template

 
Finances Management 

Budget Monitoring tool

 

Budget Monitoring tool with example data

 
Essential Documents     

Essential documents checklist

 Investigator site file (Master File) set up and maintenance SOP

Trial Master File Contents List

Archival of essential documents SOP

 

Archiving trial data SOP

 

Investigator brochure or IMP dossier development SOP

 Enrolling and retaining participants, managing visits          

Enrolment log

Screening SOP

Subject identification log template

Recruiting study participants SOP

Subject screening log template

Follow up visits SOP

Subject visit log vaccine trial

Pre and post admission study team meetings SOP

Subject visit log any trial

Blood Sampling SOP

Subject withdrawal and termination log

Reimbursement of Study Subjects SOP

Pre-screening eligibility check template

Transfer of patients SOP

Screening procedures

 

Interviewer recruitment log

 

Participant communication log

 

Interviewer follow up form

 
Informed Consent and Counselling        

Informed consent template - generic

Audiovisual recording of informed consent SOP

Informed consent template for clinical trials

Reviewing and obtaining informed consent SOP

Informed consent template for observational in-patient clinical trials

 

Informed consent template for interviewing research studies

 

Informed consent template sampling only

 

Monitoring informed consent checklist

 

Subject informed consent log template

 

AudioViual recording informed consent checklist

 

Opinion leader inputs - meeting records

 

Informed Consent Sample only in household community

 
Providing clinical care  

Concomitant medication log

Managing biological samples SOP

 

Preparation for clinical conduct SOP

 

Transfer of patients SOP

Handling Biomedical Products   

Blood Sampling SOP

 

Managing biological samples SOP

IMP Management         

Drug accountability log template

Receiving IMP SOP

Drug supplies record template

Packaging and labelling IMP SOP

Acknowledgement of IMP receipt template

Disposal of IMP SOP

Pharmacy Accountability form template

Managing IMP SOP

Packing of IMP form template

 

Investigator IMP accountability form

 

IMP return form template

 

Receipt for IMP destruction

 

IMP Temperature log

 

Lab selection form

 
Data Management     

Data handling study team agreement

Data Recording SOP

Data clarification form

 

Data management plan

 

CRF template -generic malaria

 

CRF template generic

 

CRF tracking template

 
Data Collection  

CRF template -generic malaria

Data Recording SOP

CRF template generic

Blood Sampling SOP

CRF tracking template

 
Study and Site Management    

Trial contacts sheet

Investigator site file (Master File) set up and maintenance SOP

Logs List Template

Communication with sponsor or contract research organisation SOP

Essential documents checklist

 

Trial Master File Contents List

 
 Study Initiation 

Site initiation checklist

Site initiation, activation and close out SOP

Site readiness checklist for vaccine trial

 
Study Close   

Study Close-Out - Premature termination checklist

Site initiation, activation and close out SOP

 

Archival of essential documents SOP

 

Archiving trial data SOP

Site Selection         

Site selection visit form

Identifying Critical Suppliers SOP

Site selection visit checklist

 

Site assessment and feasibility questionnaire

 

Site assessment questionnaire template

 

Site Feasibility Tracker

 

Site Feasibility Contact Log

 

Site feasibility report

 

Site initiation checklist

 

Site readiness checklist for vaccine trial

 

Lab selection form

 
 

Staff Management

  

Master training log

Communication with sponsor or contract research organisation SOP

Delegation of authority log

Study team training and study handover SOP

Study team responsibilities

 
Ethics and Human subjects Protection         

Ethics committee application letter format

Reviewing and obtaining informed consent SOP

Ethics committee submissions checklist

Audiovisual recording of informed consent SOP

Informed consent template - generic

Risk Assessment for Trial SOP

Informed consent template for clinical trials

Emergency Scenario Training SOP

Informed consent template for observational in-patient clinical trials

 

Informed consent template for interviewing research studies

 

Informed consent template sampling only

 

Informed Consent Sample only in household community

 

Subject informed consent log template

 

Monitoring informed consent checklist

 

AudioViual recording informed consent checklist

 

Ethics committee approval letter template

 

Risk assessment template

 

Interactions with IEC (Institutional Ethics Committee) SOP

 
Risk, Safety and Adverse Events (AEs) Management

Adverse Event Record

Safety assessment and reporting SOP

Adverse Event Log Template

Risk Assessment for Trial SOP

Serious adverse events log

Non compliance to protocol SOP

SAE reporting checklist

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Emergency Scenario Training SOP

Serious adverse events form template

 
Agreements, approvals and contracts

Clinical trial agreement

Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs') SOP

Clinical trial agreement log

Interactions with IEC (Institutional Ethics Committee) SOP

Confidentiality and NDA Template

 

Interviewer contract English

 

Interviewer contract French

 

Data handling study team agreement

 

Regulatory binder table of contents

 

Ethics committee approval letter template

 
Quality Assurance

Monitoring checklist – internal

Non compliance to protocol SOP

Monitoring activities Template

Monitoring visits SOP

Monitoring agreement for local independent safety monitor template

Monitoring SOP

Monitoring informed consent checklist

 

Monitoring plan template

 

Monitoring visit log

 
Protocol Adherence

Protocol deviation log

Non compliance to protocol SOP

Protocol training log

Protocol amendment assessment SOP

Protocol violation log

 

 

To share your own templates and SOPs, or comment on these, please email info@globalhealthtrials.org. We look forward to hearing from you!

 

Reply

  • kyawtun Kyaw Myo Tun Nov. 18, 2012

    Excellence tools!

  • Mohamadou Mohamadou Nov. 29, 2012

    great educative tools!

  • xcellent

  • thokozilemashaah Thokozile Mashaah June 4, 2013

    lots of useful tools which we can use as we are trying to develop tools for clinical research

  • jobygeorge05 Joby George June 15, 2013

    Do you have SOP ON RESEARCH MISCONDUCT,IF YES PLZ UPLOAD

  • GHN_Editors The Editorial Team June 17, 2013

    Dear Joby. Nobody has so far shared a research misconduct SOP on this site - why don't you try posting on the discussion forums (go to "community" and then "groups" - and requesting one)?

    However, a search on google did show a few which may be of use to you in the meanwhile. For example:

    Imperial College London: https://workspace.imperial.ac.uk/clinicalresearchgovernanceoffice/Public/JRCO_SOP_036_Research%20misconduct%20Final%202012.pdf

    Sonteybrook research: http://www.stonybrook.edu/research/orc/research-misconduct-sop.pdf

    When you've built one for your study, please do share it here so that others can use it too!

  • jneana Dr Joseph Ana June 18, 2013

    Regarding SOP for Research Misconduct, We use SOP / guidelines by various other institutions and organisations:

    - COPE ( committee on publication ethics) guidelines
    - ICJME ()international committee of journal editors)
    - WAME (world association of medical editors).

    Institutions like the Imperial College, London : SOP Ref No: JRCO/SOP/036 Final v2.0 03/12/12 Page 1 of 5 © Imperial College of Science, Technology and Medicine

  • GHN_Editors The Editorial Team July 26, 2013

    Dear Joby,

    thank you for sharing your SOP on Protocol Development - we have added this to the list on the right hand side for others to use. Much appreciated, and I hope you found everything you needed for your SOP on research misconduct.

    The Editorial Team

  • dralinn ALI Innocent Aug. 30, 2013

    Hi Dr Joe

    I am delighted you found this website. I earlier introduced it to you because of your prolific interest in health care information and resource sharing....

  • shailajadr Shailaja March 11, 2014

    Fantastic resources

  • GHN_Editors The Editorial Team March 11, 2014

    Thank you for your kind comments.

  • amanirak Alexandre Manirakiza April 8, 2014

    This site is impeccable and very useful for my job!!!!

  • ndurran Nazish Durrani April 25, 2014

    Hi,
    I am new to this website and also to the Clinical Research Industry for that matter I only am able to see the PDF of these courses, just wanted to know are these audio lectures and also happen to have audio clips that go with the pdf?

  • GHN_Editors The Editorial Team April 28, 2014

    Hi Nazish, and welcome to the Network. The items here are downloadable templates for you to use; it sounds like you may be seeking lectures and eLearning courses? If so - no problem! You can find free seminars with sound and slides here: https://globalhealthtrials.tghn.org/elearning/e-seminars-new/, and you can find free, certified eLearning courses here: https://globalhealthtrials.tghn.org/elearning/other-resources/. Certificates are awarded for the eLearning courses for those scoring over 80% in the quiz at the end of each course.
    If you need anything else, do ask!
    Kind regards
    The Editorial Team

  • ndurran Nazish Durrani April 29, 2014

    Thanks so much. These are very helpful seminars. Please let me know any other websites/links that provide free or inexpensive lectures on clinical Research. Appreciate your help.

  • GHN_Editors The Editorial Team May 1, 2014

    Dear Nazish

    Thank you, I am glad you found the seminars and the training courses useful. We list many training events (all relevant to Global Health, and as many of them as possible are either free or subsidised) on the 'community' web pages above. Keep an eye on those for events and activities which you can get involved with. Also, if you post an 'introduction' on the introduction group stating where you are from and your research interests, we can keep you updated of relevant local events.

    Kind regards
    The Editorial Team

  • GHN_Editors The Editorial Team May 1, 2014

    We also have an up to date list of global health events available here: https://globalhealthtrials.tghn.org/community/training-events/

  • Estimados: me parece excelente el aporte que han hecho dado que aporta. por un lado a mejorar la transparencia del trabajo como a facilitar el seguimiento y supervisión de los mismos. Muchas gracias por ello

  • gamanyagg Getrude Gamanya Sept. 26, 2014

    need modules on free online gcp course on research ethics

  • GHN_Editors The Editorial Team Oct. 29, 2014

    Dear Getrude

    We have a free 14-module course on research ethics on our training centre; you'll receive a certificate if you complete all the modules and quizzes. You can take it in your own time. Just visit 'Training centre' in the tabs above, then 'short courses'.

    Kind regards
    The Editorial Team

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