Reporting Recruitment

The JRO has produced comprehensive guidance on reporting study recruitment figures.

Access the guidance.

Below we summarise reporting requirements and then outline which pages of the guidance may be most relevant to you depending on your situation.

What do we mean by recruitment?

Recruitment is the “enrolment of an individual person meeting specific inclusion criteria into a research study”. Recruitment includes those who have “both provided informed consent to join a study”  and those participants who “count towards the sample size of the study as set out in the study protocol” (NIHR CRN Recruitment Policy Document | NIHR).

Reporting requirements

Researchers are required to report the number of participants recruited into their studies. There are 4 groups which have an interest in this data:

• The sponsor
• The site
• The NIHR Clinical Research Network (for studies which are NIHR adopted)
• The Research Ethics Committee (REC)

Where should I report recruitment and when?

During the setup of the study, the study sponsor will provide instructions to Chief and Principal Investigators on the requirements for recording recruitment.  Guidance for reporting recruitment where UCLH is a site can be found below.

Chief Investigators should provide an annual progress report to the NHS REC and to the sponsor.

For studies which are NIHR adopted,  there is an additional requirement to provide recruitment numbers to the NIHR. Further information be found below.

Reporting recruitment for NIHR adopted studies (only)

The site research team must log recruitment through a local portfolio management system (LPMS). Each region has its own LPMS system. At all sites within North Thames Local Clinical Research Network, the LPMS system is called EDGE. The R&D department or Local Clinical Network will provide guidance on the appropriate use of the LPMS.

Site data is entered into each LPMS., This  is automatically sent to a national record for each study. This national record is held within a database called the Central Portfolio Management System (CPMS).  

Chief Investigators (CIs) validate the information from sites within the CPMS. CI’s can invalidate or query CPMS data and request sites correct the data.  

My study is happening at UCLH; where should I report recruitment?

Enrolment to all studies at UCLH should be recorded within the electronic patient record (EPIC). There is no additional requirement to report to the R&D office at UCLH.

For NIHR adopted studies, the LPMS covering UCLH is called EDGE. For studies taking place at UCLH (only) there is no additional requirement to report recruitment to the LPMS. The R&D office (JRO) will transfer recruitment numbers from EPIC to EDGE on behalf of the PI. 

There are a few exceptions, e.g. where the NIHR and sponsor have advised on a “manual” upload or where UCLH staff are participants. In such cases, the site team will need to submit recruitment to the LPMS and EPIC (if applicable).

My study recruits UCLH patients

• You need to associate the patient on Epic, in accordance with the relevant tip sheet here.
• Where the study is NIHR adopted and requires manual upload of data to NIHR systems, you must also add the recruitment into LPMS directly.

 The following pages of the JRO guidance are most relevant:

My study is happening at UCLH but does not recruit UCLH patients (e.g. participants are UCLH staff members)

• You will need to add recruitment directly into EDGE.

The following pages of the JRO guidance are most relevant:

My study is NIHR adopted, and I need to check whether any UCLH recruitment data has yet to be validated or deemed inaccurate

The following pages of the JRO guidance are most relevant:

I am a CI on a study; where should I report and check recruitment?

The CI on an NIHR adopted study should regularly check and validate data submitted by sites. This is completed through CPMS.

The following pages of the JRO guidance are most relevant:

The CI on a non-NIHR adopted study, should regularly report recruitment to the sponsor. The sponsor will verify the requirement during set-up procedure for the study.

I am a CI and I need to submit an annual progress report to the relevant regulatory agencies

The following page of the JRO guidance are most relevant: