Annual Progress Report to Main Research Ethics Committee

ANNUAL PROGRESS REPORT TO MAIN RESEARCH ETHICS COMMITTEE

(For all studies except clinical trials of investigational medicinal products)

To be completed in typescript and submitted to the main REC by the Chief Investigator. For questions with Yes/No options please indicate answer in bold type.

1. Details of Chief Investigator

Name: / Professor Lee Shepstone
Address: / School of Medicine, Health Policy & Practice
University of East Anglia
Norwich
NR4 7TJ
Telephone: / 01603 592100
Email: /
Fax:

2. Details of study

Full title of study: / A pragmatic randomised control trial of the effectiveness and cost-effectiveness of screening for osteoporosis in older women for prevention of fractures – The SCOOP study
Name of main REC: / North West REC
REC reference number: / 07/H1010/70
Date of favourable ethical opinion: / 20/09/07
Sponsor: / University of East Anglia

3. Commencement and termination dates

Has the study started? / Yes / No
If yes, what was the actual start date? / 01/02/07 (ie. funding start date)
If no, what are the reasons for the study not commencing?
What is the expected start date? / Not applicable
Has the study finished?
If yes, complete and submit “Declaration of end of study” form, available at / Yes / No
If no, what is the expected completion date?
If you expect the study to overrun the planned completion date this should be notified to the main REC for information. / 30/04/2014 (ie. funding end date)
If you do not expect the study to be completed, give reason(s) / Not applicable

4. Site information

Do you plan to increase the total number of sites proposed for the study?
If yes, how many sites do you plan to recruit? /

Yes / No

5. Recruitment of participants

In this section, “participants” includes those who will not be approached but whose samples/data will be studied.

Number of participants recruited: / Proposed in original application:11,580
Actual number recruited to date:12,495
Number of participants completing trial: / Actual number completed to date:None – all participants will be followed up for a minimum of 5 years until the end of the trial in 2014.
Number of withdrawals from study to date due to:
(a) withdrawal of consent 184 /12,495 (1.5%) randomised participants have withdrawn consent for the study to access health records for the purpose of collecting outcome data. NB. This figure includes 17 participants that were reported as having died after withdrawing consent, plus 1 lost to follow-up.
(b) loss to follow-up 30 /12,495 (0.2%) randomised participants are currently lost to follow-up, not including those that have also died or withdrawn consent to access health records.
(c) death (where not the primary outcome) 236 / 12,495 (1.9%) randomised participants are reporting as having died – this does not include the 15 deaths reported in a) above.
Total study withdrawals:
450 (3.6% randomised participants)
*Number of treatment failures to date (prior to reaching primary outcome) due to:
(a) adverse events
(b) lack of efficacy
Total treatment failures:
The intervention in this RCT is a screening programme to identify participants that are at increased risk of fracture. A proportion of those identified as being at increased fracture risk will commence treatment on established medication for the prevention / treatment of osteoporosis under the management of their GP, ie. the drug treatment itself is not the primary focus of the intervention, and we cannot provide comprehensive data regarding non-adherence with that treatment. Therefore we do not feel it is appropriate to complete this section.
* Applies to studies involving clinical treatment only
Have there been any serious difficulties in recruiting participants? /

Yes / No

If Yes, give details: / Not applicable
Do you plan to increase the planned recruitment of participants into the study?
Any increase in planned recruitment should be notified to the main REC as a substantial amendment for ethical review. /

Yes / No

This study has already over-recruited compared to the original target, as reported in section 5 of this report. The reasons for over-recruitment were stated in a letter to the REC dated 16/11/09 as part of the correspondence regarding Substantial Amendment 2.

6. Safety of participants

Have there been any related and unexpected serious adverse events (SAEs) in this study? /

Yes / No

Have these SAEs been notified to the Committee?
If no, please submit details with this report and give reasons for late notification. /

Yes / No /Not applicable

Three separate SAEs have been notified to the REC via the relevant SAE report forms on 21/07/08, 23/06/09 and 21/08/09.
Have any concerns arisen about the safety of participants in this study?
If yes, give details and say how the concerns have been addressed. / Yes / No

7. Amendments

Have any substantial amendments been made to the trial during the year? /

Yes / No

If yes, please give the date and amendment number for each substantial amendment made. / Substantial amendment 2.3 submitted on 01/10/09.
(The only other substantial amendment was 2.2 submitted on 16/12/08).

8. Serious breaches of the protocol

Have any serious breaches of the protocol occurred during the year?
If Yes, please enclose a report of any serious breaches not already notified to the REC. / Yes / No
Yes / No
Not applicable

9. Other issues

Are there any other developments in the study that you wish to report to the Committee?
Are there any ethical issues on which further advice is required?
If yes to either, please attach separate statement with details. / Yes / No
Yes / No

9. Declaration

Signature of Chief Investigator: /
Print name: / Professor Lee Shepstone
Date of submission: / 20/09/2010

Annual progress report (non-CTIMP), version 4.1, dated September 2009

Progress_report_non-CTIMP 4.1 for submission Sep10.doc