Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mrs H Rogers


Contact details

Clinical Trials Unit
The Cardiothoracic Centre
Thomas Drive
L14 3PE
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised controlled trial to evaluate a novel CD-ROM learning package against the standard lecture - training system for research governance in the teaching of new researchers in an NHS Trust


Study hypothesis

Is the use of a CD-ROM teaching package more cost effective than traditional lecture methods of teaching Research Governance to new researchers?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Not Applicable: Education


The purpose of this study is to determine whether a CD-ROM can provide education in research governance to new researchers as effectively but more cheaply and conveniently than routine lecture teaching. A CD-ROM teaching package has been produced that is identical to a Power point teaching presentation. Staff at the Cardiothoracic Centre - Liverpool NHS Trust who have research as part of their job description will be invited to attend a half day study day in the lecture theatre of the hospital and provided with an information sheet to decide if they wish to take part in the study or not.

On arrival in the lecture theatre subjects will be asked to consent to the study. Those who do will be randomised by pre numbered envelopes prepared by the clinical governance department.
1. Those subjects randomised to lecture will remain in the lecture theatre and receive 2 hours of the power point presentation with hand outs and web site addresses so that they have identical information to the CD-ROM group.
2. Those randomised to CD-ROM will be provided with a disc containing the PowerPoint presentation, web links and copies of important documents. They will be able to use this at home or with assistance from the librarian in the library.

All participants will be requested not to discuss source documents with other members of the research group. They will also be requested to return in 2 weeks time for a knowledge multichoice questionnaire and a satisfaction survey.

Intervention type



Not Specified

Drug names

Primary outcome measure

1. Cost effectiveness will be measured by cost per hour per attendee taking into account only direct costs, with the assumption that the CD-ROM will be used for the same length of time as the lecture. Subjects who do not attend the exam will be considered exam failures and their data will be included in the cost effectiveness. Subjects who attend the exam but obtain less than the 50% pass mark will also be considered exam failures.
2. Satisfaction with the teaching method will be analysed via Lickert scale questions from Price J 2005 and written responses to open ended questions.

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Participants will be identified by obtaining lists of staff on Banding 6 & 7 with research as part of their job description. These staff will then be approached by letter also enclosing a study information sheet. Participants will be recruited and consented on attendance at the lecture theatre for the teaching session.

Subject inclusion criteria:
1. Age > 18 years
2. Able to give informed consent
3. Research active
4. Employee of the Cardiothoracic Centre - Liverpool NHS Trust

The sample size has been calculated to detect a £2.50 difference in cost using a 2 sample t test .at 90% power with a mean population wage of £ 20.46 and a standard deviation of 1.8. This will be calculated by taking the direct costs of subject wages per hour spent learning and the unit cost of the teaching method. This provides a sample size of 24 (12 in each arm of the study). To allow for drop outs and to obtain 24 evaluable questionnaires a total of 30 subjects will be enrolled.

Participant type


Age group



Not Specified

Target number of participants


Participant exclusion criteria

1. Unable to take ½ day for teaching and follow-up
2. No access to computer
3. Involved in another study within the last 30 days

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials Unit
L14 3PE
United Kingdom

Sponsor information


Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)20 7307 2622

Sponsor type




Funder type


Funder name

The Cardiothoracic Centre Liverpool NHS Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/10/2017: No publications found, verifying study status with principal investigator.