Downloadable Templates and Tools for Clinical Research
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 ...
Templates • Global Health Trials
To share your own templates and SOPs, or comment on these, please email [email protected]. We look forward to hearing from you! ... (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 ...
Tools • Global Health Trials
The map is designed as a guidance tool – by working through the map you are taken through the various stages that may be required to initiate your clinical trial. Click on each box to be taken through to guidance, links, discussions and templates. Adverse experiences This is a form to use or adapt, for parents and guardians of a child taking ...
Home • Global Health Trials
Join WHO and The Global Health Network for an in-depth look at the groundbreaking WHO guidance on clinical trials, aimed at sustained capacities, integrating research into health systems, and fostering diverse, active research networks worldwide. This session offers valuable insights directly from WHO leaders on how the new framework can enable ...
Article: Informed Consent Templates • Global Health Trials
These templates aim to guide the investigator when they need to develop their own study specific information sheet and consent form. Each template should be carefully adapted for a protocol. In Kilifi these templates are intended for use with protocol specific standard operating procedures (SOP). These SOPs detail precisely how the information ...
Blood Pharmacokinetics • Global Health Trials
Blood pharmacokinetic sample collection, processing and transport in COVID-19 clinical trials. While a trial protocol will describe which drug concentration (or pharmacokinetic, PK) samples are to be collected and when, and how such samples will be prepared for analysis, it is important that site staff understand the rationale and best practice for PK sampling to help ensure robust …
Making a Standard Operating Procedure manual (SOP)
SOPs can be updated as necessary, but because they form the 'how to' for each step of the trial process, it's important to keep track of which version is which (usually dating the footer is a good idea and keeping a log of all your SOPs and which one is the latest of each version). The team working on your trial should read the relevant SOPs ...
Resources • Global Health Trials
Find documents, guidelines, and templates on Research Topics such as Ethics and Data Management. Downloadable Tools. A process map to help you initiate a trial, tools to help you write protocols, the CONSORT guidelines, among others. Downloadable Templates
Protocols, SOP's and MOP's..... helpful or just more paper?
Typically studies have between 5 and 10 SOP’s....not 70! My ideal SOP is a single page laminated and stuck on a clinic or laboratory wall. There are some examples in the articles on this site. A MOP can be very helpful and many researchers groups have a single 'MOP' for the whole study and then short SOP's extracted as reminders, often placed ...
Templates and Logs from a Trial in India
This requires coordination and collaboration of different groups from different departments. These logs are comprised of essential checklists based on ICH-GCP guidelines enlisting all the important steps required for clinical trials. These checklists will serve as tools for clinical research professionals for executing clinical trials in time ...