- On this site
- Across the Global Health Network
Online Introductory Course for Members of a Research Ethics Committee
...Protocols, Operations and Functions of RECs, Principles of Informed Consent, How to Evaluate Risks a...
https://globalhealthbioethics.tghn.org/community/blogs/post/3255/2013/01/online-introductory-course-for-members-of-a-re/
Preparing for Lassa vaccine clinical trials with targeted epidemiology studies
...protocol elements for targeted epidemiology studies. The agenda of the meeting can be found in Annex...
https://cepi-tr.tghn.org/articles/preparing-lassa-vaccine-clinical-trials-targeted-epidemiology-studies/
Zika epidemic and microcephaly in Brazil: Challenges for access to health care and promotion in three epidemic areas
...Protocols. A threshold radius of 100 km was stablished as the maximum distance from municipalities c...
https://fiocruz.tghn.org/articles/zika-epidemic-and-microcephaly-brazil-challenges-access-health-care-and-promotion-three-epidemic-areas/
Resources Library
...Protocol Development
Data Management
Adverse Event Reporting
...
https://tesa.tghn.org/resources/resources-library/
Why we need easy access to all data from all clinical trials and how to accomplish it
...protocols, have increased in recent years. Such calls have come, for example, from the Organization ...
https://globalhealthdatamanagement.tghn.org/articles/why-we-need-easy-access-all-data-all-clinical-trials-and-how-accomplish-it/
Access to regulatory data from the European Medicines Agency: the times they are a-changing
...protocols.
In conclusion, regulatory data are an indispensable source for systematic reviews. Becau...
https://globalhealthdatamanagement.tghn.org/articles/access-regulatory-data-european-medicines-agency-times-they-are-changing/
SA Medical Research Council Verulam Clinical Research Site
...protocol-specified timelines, on budget, and with excellent data quality. Research Clinicians, Pharm...
https://sitefinder.tghn.org/sites/sa-medical-research-council-verulam-clinical-research-site/
Contracts agreed
Process Map
...protocol may serve as the basis of a contract” (EMEA, 2009).
More formal contracts are often ...
https://processmap.tghn.org/?mapnode=contracts-agreed
Regulatory approvals submission
Process Map
...protocols in the Guideline for Good Clinical Practice E6(R1):- General information- Background infor...
https://processmap.tghn.org/?mapnode=regulatory-approvals-submission
CREDO - Research Study Planning and Governance
Global Health Training Centre
...protocol was developed
Example
Commercial institution
Developed the protocol for ...
//globalhealthtrainingcentre.tghn.org/elearning/education/credo/credo-research-study-planning-and-governance/
Introduction to Collecting and Reporting Adverse Events in Clinical Research
Global Health Training Centre
...protocol should outline what is, for the purpose of the study, considered to be an adverse event, ho...
//globalhealthtrainingcentre.tghn.org/elearning/education/elearning-courses/introduction-to-collecting-and-reporting-adverse-events-in-clinical-trials/
Go ZIKA Go
...protocol as illustrated below.
Originally published at Int J Environ Res Public Health. 2020 Sep ...
https://rede.tghn.org/exemplar-projects/go-zika-go/
Notes on How to Survive a GCP Audit forum discussion based on the GCP Inspection Course (Global Health Network eLearning course)
...protocol). An option is to circulate a memo of clarification after team meetings to highlight pertin...
https://globalhealthbioethics.tghn.org/articles/notes-how-survive-gcp-audit-forum-discussion-based-gcp-inspection-course-global-health-network-elearning-course/
Finalise SOPS
Process Map
...protocol into meaningful and detailed instruction that are written, ideally by those who will be car...
https://processmap.tghn.org/?mapnode=finalise-sops
Africa
...protocol to report on the perceptions of Healthcare Workers during the pandemic. To date, four teams...
https://arch.tghn.org/regions/africa/
Protocol Tool 2021 Portuguese
...protocolo.
A ferramenta Concept Protocol Crowd Review disponível aqui no EDCTP K...
https://edctpknowledgehub.tghn.org/protocol-development/Ferramentas-portuguese/
Do you need help with your trial?
...Protocol Tool has a very useful sections on population, sample size, analysis strategies and statist...
https://globalhealthtrials.tghn.org/community/groups/group/general/topics/8/
April Issue of the Month: Research Misconduct and Withholding unfavourable results - what can be done?
...protocols with the methods used is not the only solution, but the big solution i would think is for ...
https://globalhealthtrials.tghn.org/community/groups/group/trial-management/topics/334/
Information Sessions for study staff
Process Map
...protocol.
With the team together, someone should lead a discussion that talks through the whole pro...
https://processmap.tghn.org/?mapnode=information-sessions