Accrual frequently asked questions

A1. What is accrual?
Accrual is an individual incidence of recruitment to a study on the NIHR CRN Portfolio.

A2. Why do I need to provide accrual data?
The key purpose of the NIHR Clinical Research Network (CRN) is to ensure the effective provision of clinical research infrastructure / NHS service support so that more NHS clinicians can contribute to clinical research and so that more NHS patients and organisations can benefit from being part of a research study. Accrual data are a key part of the information used to monitor and improve the work of the CRN. These data will also feed into the process of allocating future funding to the NIHR Comprehensive Local Research Networks (CLRNs) to ensure that infrastructure / NHS service support are directed to where they are required. A list of CLRNs and further information can be found on our website at: http://www.crncc.nihr.ac.uk/index/networks/comprehensive/clrns.html

A3. What forms can accrual information take and how is it recorded?
Accrual data are data relating to:

• patients recruited to a treatment regime
• staff members who have completed questionnaire(s) or been interviewed in research 
• individual members of focus groups
• the collection of tissue or blood samples during research
• participants who have answered questions during research.

In each of these situations a line of data should be provided, by the named accrual contact for the study, for each recruit that has consented to participate during the study.

Where an accrual event occurs twice in the same study, e.g. a staff member completes two questionnaires or a sample is tested twice, the accrual is only normally counted once.

A4. For reasons of confidentiality we do not hold the dates of birth/genders/postcode of our participants is this information required?
No. This is not mandatory information; it is only those columns in red that are mandatory. The other/non-mandatory columns can be left blank on the spreadsheet.

A5. We have not gained consent from our participants to pass their information onto a third party. Does this mean that we are unable to pass the information onto the NIHR CRN CC?
You are able to pass information to us. Security of information pertaining to participants in the studies registered on the Portfolio is extremely important to us. The fields on the spreadsheet that provide information which could identify the patient directly are not mandatory. We also ask that you ensure your Study Patient Number is not a hospital or NHS number or any other type of data that could identify an individual patient. None of the mandatory data required, therefore, should directly identify the patient. We do not publish the detailed accrual data you provide us with; only total numbers of study participants are made publicly available.

A6. For which time period(s) is data required?
A line of data is required for every study participant recruited from 1 April 2008 onwards. We encourage study coordinators to provide a line of data for each participant recruited prior to April 2008 wherever possible, to ensure data completeness. Where this is not possible we request that total numbers of recruits are submitted. When providing total numbers these should be submitted to the accrual team as two figures; recruitment for April 2007 to March 2008 inclusive and recruitment prior to April 2007. Totals should include all recruitment, including international recruits (see below).

A7. Should I provide information on study participants from the Devolved Nations or from other countries?
Data for participants recruited in the Devolved Nations (Scotland, Wales and Northern Ireland) should be included. The Portfolio database will allocate data to the appropriate Clinical Research Networks for resource allocation purposes. Recruits from outside the UK should not have a row of data listed, but should be included in the running total. As you may have seen on the Portfolio database, entries for non-commercial studies that are open have a percentage bar to indicate how far forward they are with recruiting their planned sample size. This bar is calculated from the running total column in your spreadsheet. Therefore if you omit patients recruited from outside the UK from your running total it will appear as if you are underachieving against your planned sample size.

A8. I have a number of control subjects and healthy volunteers as well as those suffering from the disease I am studying. Is there anyway to record this in the accrual data?
Yes. The spreadsheet has a column entitled “RecruitType”, this column uses ones and zeros to denote whether the subject is a healthy volunteer (0) or a sufferer of the disease in question (1).

A9. Our study is open to recruitment, but we have not recruited anyone. Can we record this?
Yes, there is a specific process for logging the fact that there has not been any recruitment. This is outlined in the Accrual Upload User Guide available at: http://www.crncc.nihr.ac.uk/index/library/ info_sys.html

A10. The research question that my study is addressing is part of a larger programme of research work which is already registered on the Portfolio and is submitting accrual. Should I submit my study for inclusion on the Portfolio as a study in its own right and then report accrual separately for this sub-study?
For the purposes of the Portfolio, a study is generally defined as a structured research activity which is the subject of a single ethics approval. Therefore, if the research question being addressed in the sub-study, or “nested study” is covered by the ethics approval which covers the main study, the sub-study would not be viewed as a separate study in its own right and accrual would not be submitted for this study separately as it will already be being collected for the main study. However, if the sub-study or “nested” study is the subject of a separate ethics approval and patients who have previously consented into the main study were required to additionally consent into the sub-study, then the sub-study would be considered as a study in its own right, would need to be considered as a study in its own right, would need to be considered for acceptance onto the Portfolio and would report accrual separately.

A11. My study does not involve the recruitment of patients but is addressing a “Service Delivery, Organisation” type of research question which involves the collection and analysis of information relating to organisations, e.g. GP practices/nursing homes/hospital wards, how do I record this?
Where a study involves individuals, e.g. interviews with GP Practice Managers/NHS staff to research the outcomes of changes to the pattern of service delivery, then each individual who takes part in the study should be recorded as a single accrual. If however, the study is pitched at the level of whole organisations and does not involve individuals in any way, then the number of organisations (e.g. GP practices) which are contributing in some way to the study should be reported as the accrual.

A12. The patients participating in my study are being recruited at their local GP practice, however the research project which they are involved in is taking place in a hospital.Should I report the accrual site name as the GP practice or the hospital?
In general, the site where the patient is consented should be listed as the accrual site. This is on the assumption that, in general, the site where the patient is consented is the research site where most of the NHS infrastructure support is required. If however, this is not the case, then discretion should be used, and the local CLRN should decide which is the most appropriate site to be linked to the accrual.

A13. My study team is under resourced and therefore cannot complete this request for accrual data. Can I obtain resources elsewhere to support this?
The Comprehensive Clinical Research Network (CCRN) was set up to provide infrastructure support to clinical research in the NHS. The support provided by the CCRN can include appropriate staff costs, such as Data Managers and Research Management staff and other service support. You should therefore direct queries of this nature to your Topic or Comprehensive Local  Research Network. Contact details of the management teams are available on the CCRN webpages.

A14. If I have further queries about collating and uploading accrual who should I contact?
Please contact the NIHR CRN CC on 0113 343 0329 or at crncc.accrual@nihr.ac.uk.

A15. Should control patients in CCRN Randomised Controlled Trials count towards primary targets? 
There is a need to work towards consistency across Networks, and therefore the following classification applies:

• RCT involving patients – these are all patients (type 1) and both test and control arms count towards targets
• Non randomised study involving patients (e.g. phase I, or phase II trial, or cohort study) – these are type 1 and count to accrual targets
• RCT in healthy volunteers (e.g. high risk people who have not yet developed disease), the subjects are type 0 and should be recorded separately for accrual targets
• Non randomised study in healthy volunteers (including in general or at risk population e.g. epidemiology cohorts) count as type 0 and are recorded separately
• In epidemiology case control studies the cases are 1, the controls are unaffected, are 0.

A16. The patients participating in my study are being recruited at their local GP practice, however the research project which they are involved in is taking place in a hospital. Should I report the accrual site name as the GP practice or the hospital? 
In general, the site where the patient is consented should be listed as the accrual site. This is on the assumption that, in general, the site where the patient is consented is the research site where most of the NHS infrastructure support is required. If however, this is not the case, then discretion should be used, and the local CLRN should decide which is the most appropriate site to be linked to the accrual.

A17. The patients participating in my study are being recruited in an ambulance (or within an ambulance transfer or other aspect of a service provided by an NHS Ambulance Trust). What site name should I report in the accrual data?
As the participant consented when in the care of the NHS Ambulance Trust, the name of the Ambulance Trust should be stipulated as well as the name of the hospital/site that the participant is transported to in the ambulance if that is relevant to and involved in the research.  For more information refer to the Comprehensive Clinical Research Network Resource Library.

Last updated: 31 March 2009