- On this site
- Across the Global Health Network
SOPs
...protocol. The list of activities requiring SOPS and their indexing should be detailed in the Trial M...
https://globalhealthtrials.tghn.org/community/groups/group/process_map/topics/40/
Develop Pharmacovigilance / Safety Reporting Plan
...protocoltool/TrialProtocolTool.html
5. Templates and guidelines on Safety Reporting: http://www.adm...
https://globalhealthtrials.tghn.org/community/groups/group/process_map/topics/47/
Arts in Health: Book Review
...protocol).
Arts in Health: Designing and Researching Interventions. Daisy Fanc...
https://mesh.tghn.org/articles/arts-health-book-review/
Sharing individual level data from observational studies and clinical trials: a perspective from NHLBI
...protocol focused on balancing the interests of study participants, study investigators, and the rese...
https://globalhealthdatamanagement.tghn.org/articles/sharing-individual-level-data-observational-studies-and-clinical-trials-perspective-nhlbi/
Cepheid GeneXpert
...Protocols
Running the test (hub configuration) | Running the test (tablet configur...
https://pandora.tghn.org/covid-19-diagnostic-tools/cepheid-genexpert/
image_testing_16052017
...protocols and for ethics committees in reviewing proposals for ethical acceptability. Key inte
rn...
https://globalhealthtrials.tghn.org/image_testing_16052017/
Submit to Ethics Review
Process Map
...protocol. Any substantial amendment to the protocol would need to be submitted before implementing (...
https://processmap.tghn.org/?mapnode=submit-ethics-review
Set up oversight committees stated in QA plan
Process Map
...Protocol Review committee, as their role can be all encompassing.
Protocol Review CommitteeIn most ...
https://processmap.tghn.org/?mapnode=oversight-committees
Health Systems
...protocols.
A final version of the protocols and study materials have been shared and can be a...
https://coronavirus.tghn.org/open-working-groups/health-systems-and-policy-research/
Implement 2021
...protocol will form the basis of the information you are required to enter to register your trial.
...
https://edctpknowledgehub.tghn.org/implement-2021/
Study Initiation visit – check all procedures in place
Process Map
...protocol, that all the operational steps are in place, and that everyone is clear and well trained i...
https://processmap.tghn.org/?mapnode=study-initiation-visit
Are study supplies ready?
Process Map
...protocol should be analysed, otherwise it represents a protocol violation and could be unethical. Th...
https://processmap.tghn.org/?mapnode=study-supplies-ready
Justify 2021 French
...protocole, qui est un concept utile à vérifier en cours de route, « le protocole...
https://edctpknowledgehub.tghn.org/protocol-development/justifier-french/
Intervention and Laboratory organisation, supply and logistics
Process Map
...protocol should be analysed, otherwise it represents a protocol violation and could be unethical.
T...
https://processmap.tghn.org/?mapnode=intervention-laboratory-organisation-supply-logistics
Resources Library
...Protocol Guide (MRC)
Protocol Template (MRC example)
Retrogenecity Rorm (MRC example)
Trial Proto...
https://eaccr.tghn.org/resources/resources-library/
Resources library
...Protocol Guide (MRC)
Protocol Template (MRC example)
Retrogenecity Rorm (MRC example)
Trial Proto...
https://alerrt.tghn.org/research-resources/resources-library/
ICH GCP (E6) R3 Module 2: The Principles of Good Clinical Practice
Global Health Training Centre
...protocol.
8.3 The clinical trial protocol as well as the plans or documents for the protocol...
//globalhealthtrainingcentre.tghn.org/elearning/education/ich-gcp-e6-r3/ich-gcp-MOD-2/
ICH Good Clinical Practice E6 (R2)
Global Health Training Centre
...protocol compliance
Generally, the protocol will have been signed by bo...
//globalhealthtrainingcentre.tghn.org/elearning/education/elearning-courses/introduction-to-investigators-responsibilities-with-good-clinical-practice/
REMAP-CAP
...protocol has been devloped so that eligible patients are randomised to receive one intervention in e...
https://coronavirus.tghn.org/covid-therapeutic-trials/covid-remap-cap/
Communtiy concerns about ethical conduct of research - informed consent
...protocol approved by the IRB included the need to obtain informed consent form.
• Inadequate deta...
https://globalhealthbioethics.tghn.org/community/groups/group/generaldiscussion/topics/263/