Clinical Trials Tool Kit Editorial Group
Membership
Noreen Caine - Department of Health
Sarah Dickson - MRC
Peter Dukes - MRC
Barbara Farrell - UKTMN
Sarah Meredith - MRC CTU and UKCRC
Janet Messer - NHS R&D Forum
Maxine Stead - UKCRN
Richard Sullivan - CRUK
Marc Taylor - Department of Health
Martyn Ward - MHRA
Recommendations for improvements
We reviewed the Clinical Trials Tool Kit on Monday 20th June 2005. The site has been visited over 80 000 times since it went live in October 2004, and we can estimate that there are around 3 000 regular users, which is very encouraging.
Based on the feedback we received, we have identified some issues that we propose to address. Some are easily addressed and so have been given a short timescale (within one month), and others require additional work and so have been given a timescale of medium (1-4 months) or long term (more than 4 months).
You can register to receive emails letting you know when updates to any part of the tool kit have been made.
| Issues | Strategy for improvement | Timescale |
| Reliability of information | AMRC and individual funders to link to tool kit from their websites | Short |
| Contact users that gave poor reliability feedback scores for more detailed analysis | Short | |
| Update/add information | Increase transparency about work that is underway to resolve issues | Short-medium |
| FAQs: Indentify current FAQs from sources such as UKCRN. Explore possibility of on up-to-date list for all relevant bodies (MHRA, COREC, etc.) | Long | |
| Check and correct inaccuracies: e.g. Urgent Safety Measures notification in 3 days - Regulation 30; typographical errors; broken links | Short | |
| Archiving document: update in light of GCP Directive | Medium | |
| Transitional arrangements: is Trials that began before 1st May 2004 route map still required? | Medium | |
| Changes to R&D processes: update stations and links as necessary | Short | |
| Amendments for R&D: Add information on the kind of amendments that may require R&D approval | Medium | |
| Is DH guidance on amendments required for R&D departments? | Long | |
| Reporting SUSARs: Add link to CIOMS 1 form | Short | |
| Trial Registrations: ISRCTN registration completed for NHS own-account trials, for other trials outline that there is ongoing work on trials registration | Short | |
| Phases of trials: Add definitions to glossary | Short | |
| Addition of new web pages | Add CT-TK Editorial Group page outlining membership and recommendations for improvements based on feedback | Short |
| Add a News Page (under What's New) and link to organisations News pages such as R&D Forum and BioIndustries Assoc. | Short-medium | |
| Add archiving page for out of date items | Medium | |
| Examples | Increase visibility of examples within documents by adding to Trial Scenarios section | Medium |
| Add new examples of completed documents, e.g. link to completed CTA examples on MHRA site; a completed Risk Assessment for a Trial Scenario; How to do an SOP (SOP of an SOP) | Medium-long | |
| Status of information | Distinguish between legal requirements and good practice requirements in text as well as symbols | Short-medium |
| Stipulate where ongoing work is addressing particular problems | Short-medium | |
| Glossary | Explore with web designers the possibility of an alternative layout to increase ease of navigation | Short-medium |
| Increasing awareness of CT-TK | Investigate the use of a banner on BMJ online, advertise in October | Short-medium |
| Advertise: NHS R&D Forum Newsletter regularly; individual NHS organisation R&D departments; University CT Units; Royal coilleges and societies; update in Clinical Research Focus | Short- medium | |
| Use of CT-TK in training prgrammes | Explore with training co-ordinators and Institute of Clinical Research the possibility of using CT-TK for training. Implement any simple amendments to make more training-friendly | Medium- long |
