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!

 

Also By

The Editorial Team

Categories

Trial Operations  Trial Management  Ethics and Informed Consent  Resources  Trial Design  Data Management and Statistics  

Tags

training  

Reply

  • jo8281968517 Joshy Thomas 31 Oct 2017

    I have learned lot..Thanks..

  • yfarzi yosef farzi 4 Jul 2017

    i was wondering why there is no SOP on laboratory procedures ?

  • kirannn14 Kiran Kumar 22 Apr 2017

    Hi, Can you provide me the SOP for electronic signatures in Clinical trial

  • anupambendre Anupam 26 Dec 2016

    Do you have an "SOP for Telephonic site selection visit".
    Kindly Share on my registered mail ID

  • sguteta Senbeta 9 Nov 2015

    Thank you for sharing the resources. It is very kind of you.

  • ericdortenzio Eric D'Ortenzio 7 Oct 2015

    Hi
    These tolls are very useful! Thank you

    Do you have a task and responsability matrix template for clinical trial managment ?
    Best

  • abdulkamara1986 Abdul Kamara 30 Jun 2015

    I am very much happy to find myself here as a clinician

  • GHN_Editors The Editorial Team 29 Oct 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

  • gamanyagg Getrude Gamanya 26 Sep 2014

    need modules on free online gcp course on research ethics

  • antropmcdiaz María del Carmen Rita Díaz- DNI 11445434 14 Sep 2014

    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

  • GHN_Editors The Editorial Team 1 May 2014

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

  • GHN_Editors The Editorial Team 1 May 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

  • ndurran Nazish Durrani 29 Apr 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 28 Apr 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://globalhealthtrainingcentre.tghn.org/webinars/, and you can find free, certified eLearning courses here: https://globalhealthtrials.tghn.org/elearning . 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 25 Apr 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?

  • amanirak amanirak 8 Apr 2014

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

  • GHN_Editors The Editorial Team 11 Mar 2014

    Thank you for your kind comments.

  • shailajadr Shailaja 11 Mar 2014

    Fantastic resources

  • dralinn ALI Innocent 30 Aug 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....

  • GHN_Editors The Editorial Team 26 Jul 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

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