9 Aug 2012
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 | ||
| Developing protocol | Risk Assessment for Trial SOP | |
| Disseminating findings | ||
| Finances Management | ||
| Essential Documents | Investigator site file (Master File) set up and maintenance SOP | |
| Enrolling and retaining participants, managing visits | ||
| Informed Consent and Counselling | ||
|
Informed consent template for observational in-patient clinical trials |
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| Providing clinical care | ||
| Handling Biomedical Products | ||
| IMP Management | ||
| Data Management | ||
| Data Collection | ||
| Study and Site Management |
Investigator site file (Master File) set up and maintenance SOP |
|
|
Communication with sponsor or contract research organisation SOP |
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| Study Initiation | ||
| Study Close | ||
| Site Selection | ||
|
Staff Management |
Communication with sponsor or contract research organisation SOP |
|
| Ethics and Human subjects Protection | ||
|
Informed consent template for observational in-patient clinical trials |
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| Risk, Safety and Adverse Events (AEs) Management | ||
| /td>< | ||
| Agreements, approvals and contracts |
Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs') SOP |
|
| Quality Assurance | ||
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Monitoring agreement for local independent safety monitor template |
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| Protocol Adherence | ||
To share your own templates and SOPs, or comment on these, please email info@globalhealthtrials.org. We look forward to hearing from you!
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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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Dr Joseph Ana
18 Jun 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
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The Editorial Team
17 Jun 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!
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Joby George
15 Jun 2013
Do you have SOP ON RESEARCH MISCONDUCT,IF YES PLZ UPLOAD
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Thokozile Mashaah
4 Jun 2013
lots of useful tools which we can use as we are trying to develop tools for clinical research
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Magellan GUEWO FOKENG, Bsc, Msc, PhD, FMCAYS
7 Dec 2012
xcellent
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Mohamadou
29 Nov 2012
great educative tools!
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Kyaw Myo Tun
18 Nov 2012
Excellence tools!
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