Bookmarks

Lots of clinical trial templates, resources and examples

This is an excellent website design really for US based researchers as and therefore has an NIH/FDA focus. However there are documents and examples that can be taken and ammended and they are generic for all trials and disease areas.

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The UK's clinical trial toolkit

A very detailed website based around the EU clinical trial directive aimed at those running trials in the UK. Although many of the local references to the approval processes may not apply there are some good resources and examples on this site. Many of the scenarios and guidance as generic application.

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US trial support, resources and tools

These are aimed at US based trials but there are some globally applicable resources and content.

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Set of resources from the NIH

Excellent set of materials - but are designed for use in the USA, but you can adapt to suit your situation.

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USA Clinical Trial Network

A large amount of training, resources and templates. Keep in mind these were designed for use in American but you can adapt and apply them to your specific needs and regulatory requirements

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How to prepare for a job interview and predict the questions you’ll be asked

by The Editorial Team

Job interviews can be intimidating, but simply preparing well can make the difference between succeeding or failing, regardless of how nervous you are. In this article we pull together advice on how to prepare for job interviews and how to know what questions you’ll be asked. 

2nd June 2015 • comment

Templates for Informed Consent and Participant Information Sheet

by Donna Russell

Collecting biospecimens for research from your community is a long-term commitment. It requires earning and keeping their trust by being as transparent as possible. It requires following the highest ethical, regulatory and legal standards.And it should include a mechanism for providing feedback to the community on the research that has been done using their samples. In some cases, there may be risks to ethnic and social groups or communities due to the release of aggregate research findings even when no individually identifiable information has been revealed. In addition, some populations or groups have specific beliefs about the disposition and use of their specimens, which should be respected. We provide the following templates:

  • informed consent to collect biospecimens during pregnancy
  • participant information sheet

8th January 2013 • comment

Facility checklist for biospecimen collection and storage

by Donna Russell

In determining the feasibility of establishing a biorepository at your facility, there are several key factors to consider. But first, there are a few that must be in place before commencing. They are:

  • The commitment of your institutional
  • The trust of the community within which you work
  • Informed consents that allow specimens to be used for multiple research studies
  • Vision/commitment for the distribution and sharing of biospecimens and data with the wider scientific community
We attach here the facility checklist for biospecimen collection and storage, organized by topic, along with the relevant Best Practices from ISBER, for assessing the readiness your facility. The purpose of these checklists are to 1) identify any potential barriers to setting up long-term storage of biospecimens on site; and 2) enable you to take action, as needed.

8th January 2013 • comment

Guidelines for an Integrated Approach to the Nutritional care of HIV-infected children

by Jai K Das

We share the WHO 2009 guideline that provides a framework for integrating nutrition support into the routine care of HIV-infected children (6 months-14 years). HIV-infected children deserve special attention because of their additional needs to ensure growth and development and their dependency on adults for adequate care including nutrition care and support for treatment. Vertical implementation of HIV programmes, such as PMTCT and ART, have resulted in missed opportunities to gain synergy with other existing services.

3rd January 2013 • comment

Templates from an investigator-led trial in Cameroon: the CAMPS trial (also available in French)

by Lawrence Mbuagbaw

During the setting up of our trial in Cameroon we met several operational issues that we needed to overcome. For some of these issues we developed some tools and we have made them available here so that other research groups can use them in their clinical trials.

13th May 2011 • comment

A general introduction to Biomedical Research Ethics

by Sisira Siribaddana

This article was written by a researcher from Sri Lanka and presents a very helpful overview on Biomedical Ethics. This article will be helpful to all levels of research staff and others who might want an accessible overview

26th October 2010 • comment