Performance in Initiating and Delivering Clinical Research exercise - Feedback process

Published: 01 May 2018

Version: v1.1 - September 2021

In light of the current pressures on workforce and capacity at the moment, we will be pausing the Performance in Initiating and Delivering (PID) clinical research exercise until further notice.

Please don't hesitate to contact CTP@nihr.ac.uk if you have any questions or concerns.

Acronyms

Acronyms	Title
CTP	Clinical Trial Performance
DSC	Date Site Confirmed
DSS	Date Site Selected
FPR	First Participant Recruitment
HRA	Health Research Authority
MHRA	Medicines and Healthcare products Regulatory Agency
REC	Research Ethics Committee
SOP	Standard Operating Procedure

Purpose

This Standard Operating Procedure (SOP) describes the process of data feedback for the Performance in Initiating Clinical Research exercise which informs the NIHR performance metrics for providers of NHS services.

The intention of this SOP is to outline clearly and transparently the way in which the feedback process is applied to submitted clinical trials; to promote consistency of execution of the process and common mutual understanding of expectations and requirements.

With the removal of the 70 day benchmark as of Q1 18-19, a feedback process to improve reporting accuracy will replace the previous adjustment process. The objective of the feedback process is to identify where NHS providers have reported delays in initiating clinical trials, but the explanation of these delays is unclear or incomplete. These trials will continue to be used to evaluate the broader performance of the clinical research system both locally and nationally.

Audience

The primary audience of this SOP is the Clinical Trial Performance (CTP) Team at the NIHR to use during the analysis process following quarterly submissions. This document is also intended to help and support R&D Managers, R&D Data Managers and other R&D staff, both new to the exercise and those from established submitters, to complete their quarterly returns to the NIHR in a way that achieves consistency within and across providers of NHS services.

Background

The Government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical research. The aim is to increase the number of participants who have the opportunity to participate in research and to enhance the nation’s attractiveness as a host for research. Performance in Initiating Clinical Research aims to assess the interval from the date the site is selected to recruitment of the first participant to a trial. The Department of Health places a contractual obligation on providers of NHS services contracted through the NIHR; to submit data and publish outcomes against the initiation of all clinical trials and delivery to time and to target for commercial clinical trials. More information and all related documents to support the submission process can be accessed on the submitting data on performance in initiating and delivering clinical research webpage.

Consistency in the feedback and analysis of data is important for providers to understand their quarterly performance against other providers, for the accuracy of publicly available published data. Providers are responsible for the submission of complete and accurate information.

Term	Description
Date of First Participant Recruitment (FPR)	Means the date the first eligible participant consented to the study.
Date Site Confirmed	Date of the last contract signature of all the organisations involved (i.e. sponsor, site, 3rd party) or date of final written agreement of statement of activity (as applicable)
Date Site Selected	Date on the Sponsor email received by the site providing the minimum defined documents to enable site to commence arrangement and/or confirmation of local capacity and capability as applicable representing that the site has been selected to take part in the study. Where the Sponsor is also the site, this is the date of the HRA initial assessment letter.
Feedback process	Process by which trials which have reported delays are assessed for completeness and clarity.
Matched trial	Trial where the reason for delay and the source of delay are consistent with each other and with the durations between DSS and FPR.
Mismatched trial	Trial where the selected source of delay does not correspond to the reason for delay and/or the durations between DSS and FPR.
Need More Info	Term given to a trial where no reason and/or source of delay has been selected, or where the information given is not sufficient to match the trial.
Reason for delay	Relating to the list of possible reasons for delay to clinical trials initiation, cited by the provider of NHS services for each clinical trial where a delay has been noted. The list of possible reasons can be found in Appendix 1 of this document.
Source of delay	Indicates which party was responsible for the delay: NHS Provider/Sponsor/Both/Neither.
Submission period	The period (usually 30 days) between the end of the quarter and the submission deadline
Submission window	The timeframe for which data must be submitted by the provider

Feedback Process

The feedback process is now comprised only of a data quality assessment; this feedback is intended for providers to review their data in future submissions and not for in-quarter changes. Because there is no longer a benchmark by which trials will be judged, records will not be removed from the analysis even if the delay was out of control of the NHS provider. The feedback will highlight where providers can give additional detail to create a clear and complete picture of delays. For any additional information about platform validation of data quality, please refer to the CTP Submission Platform Instructions.

Data Issue Type	Action
REC number not recognised	Feedback to trust; trials will not be excluded from the analysis solely on the basis of an unrecognised REC number
Incorrect date format	If the date is invalid or in a format which will cause formulae to fail, the dates and durations will be deleted. If the format of the date is incorrect but the information is clear, then the record is cleaned (i.e., 1-Jan-15 to 01/01/2015). For more information, please refer to the CTP Submission Platform Instructions.
Data outside the submission window	Usually occurring with Date of First Participant Recruitment; record will be cleaned to how it looked on the last day of the quarter (date of FPR deleted, duration from DSS to FPR deleted, “First Participant Recruited?” changed to ‘No’).
Data type mismatch	When numerical data appears in text fields or vice versa; these types of errors are usually picked up by the submission validation and are therefore quite rare. Where the intended information is clear (i.e., the inversion of two columns), the record will be cleaned; if there is any doubt about the intended information, the record will be excluded from analysis.
No source of delay and/or no reason for delay	Marked as ‘‘Need More Info’’, and included in the dataset.
First Participant Recruited? status is ‘Yes - Date Unavailable’	Trials will be treated as if a first participant has not been recruited, since the Date of First Participant Recruited will be blank.
HRA approval record not found	If the record cannot be matched to the HRA data using the REC or IRAS number, the following comments may be returned, depending on query results from the HRA: ‘Pre-HRA’, ‘Non-clinical trial’ or ‘Non-HRA approval’. ‘No Data’ comment will also be returned for HRA Submission Date / Date Study Initiated, HRA Country, HRA Approval Status, and HRA Approval Date if record cannot be matched to HRA data.

All trials carried forward from the previous quarter to the current quarter will be compared to the previous quarter's matching status and handled according to the following scenarios and actions:

Scenario	Action
Trial data not changed, trial previously reported delays	Matching as previous quarter
Trial data updated	Matching reassessed
Trial data not changed, but the feedback guidelines have changed and trusts have been notified at least 10 days before the end of the quarter	Matching reassessed

The following table describes the range of scenarios involving omission of data or the selection of a single delay reason, what is expected in the way of supporting information and the action in respect of match/mismatch:

Scenario	Sub-Category	Expected Source of Delay	Comments	Notes/Action
A - Relevant permissions delayed and not granted in time	HRA approval process not completed in time	Neither	Please briefly explain the reason for delay to permissions (i.e., the subcategory). Please briefly explain the nature of the delay and why the chosen source of delay is appropriate.
B - Suspended by Sponsor	Study suspended by sponsor at all sites	Sponsor	No comment required
B - Suspended by Sponsor	Study suspended by sponsor at this site	Sponsor	No comment required
C - Closed by Sponsor	Study closed by sponsor at all sites	Sponsor	No comment required
C - Closed by Sponsor	Study closed by sponsor at this site	Sponsor	No comment required
D - Sponsor Delays	Sponsor delay in provision of study documentation (e.g. pharmacy or laboratory manual)	Sponsor	Please briefly explain the nature of the sponsor delay (i.e., the subcategory) in the comments.
	Sponsor delay in provision of IMP, device or equipment	Sponsor	Please briefly explain the nature of the sponsor delay (i.e., the subcategory) in the comments.
	Sponsor delay through protocol or research application amendments	Sponsor	Please briefly explain the nature of the sponsor delay (i.e., the subcategory) in the comments.
	Sponsor delayed site initiation visit	Sponsor	Please briefly explain the nature of the sponsor delay (i.e., the subcategory) in the comments.
	Sponsor delayed confirmation of study open to recruitment at site (i.e., green light)	Sponsor	Please briefly explain the nature of the sponsor delay (i.e., the subcategory) in the comments.
	Planned and agreed later start or delay intrinsic in study design (e.g. planned later start, follow-on study, dependency on unpredictable event e.g. flu epidemic)	Sponsor	Please briefly explain the nature of the delay (i.e., the subcategory) in the comments.
E - Staff Availability Issues	NHS Provider staff availability (annual leave, sickness absence, staff issue / shortage)	NHS Provider	No comment required	NHS staff issues such as annual leave, sick leave, maternity leave, etc. are expected to be within NHS provider's control.
	NHS Provider training (e.g. GCP, protocol specific training, etc.)	NHS Provider	Please briefly explain provider training issue (i.e., the subcategory) in the comments.
	Sponsor staff availability (annual leave, sickness absence, staff issue / shortage)	Sponsor	Please briefly explain sponsor staffing issue (i.e., the subcategory) in the comments.	Sponsor staff issues such as annual leave, sick leave, maternity leave, etc. are expected to be within sponsor's control.
	Sponsor training (e.g. protocol specific training etc.)	Sponsor	Please briefly explain sponsor training issue (i.e., the subcategory) in the comments.
F – No Eligible Participants Seen	Participants screened but no eligible participants identified	Neither	Please indicate the reason no participants were seen (i.e., the subcategory) in the comments.
	Strict participant eligibility criteria / Low recruitment target	Neither	Please indicate the reason no participants were seen (i.e., the subcategory) in the comments.
	NHS Host Site's inadequate planning / feasibility arrangements to see participants	NHS Provider	No comment required
G – No Eligible Participants Consented	Eligible participants seen chose not to participate in study (e.g. Personal reasons, frequent study visits, reluctance to participate in placebo arm, preference of treatment choice, etc.)	Neither	No comment required
G – No Eligible Participants Consented	Eligible participants seen chose not to participate in study: NHS Host Site's inadequate planning /arrangements to consent participants	NHS Provider	No comment required
H - Contracting Delays	Contracting / costing delays (including service support costing and excess treatment costing, etc.)	NHS Provider Sponsor Both Neither	Please briefly explain the nature of the delay and why the chosen source of delay is appropriate.
I - Rare Diseases (Please see submission guidelines)	Rare or very rare diseases studies (as defined in the guidance)	Neither	No comment required
J - Other	Other - specify in comment	NHS Provider Sponsor Both Neither	Please only use other if no other reason explains the delay. Comments must always be included. Please briefly explain the nature of the delay and why the chosen source of delay is appropriate.	Trial will be marked ‘Need More Info’ if no comments are entered, or if the comments do not adequately explain the delay and the choice of source of delay.

Complex delays with multiple reasons for delay and/or sources of delay

It is important to capture all delays which occurred between DSS and FPR in order to gain a more complete understanding of why trials have not progressed as expected. As indicated in the table above, please provide reasons for delay between DSS and DSC and between DSC and FPR, if applicable.

As the overall aim of the exercise is to reduce the amount of time to initiate clinical trials, it is important to capture delays which could have been avoided or mitigated in order to highlight opportunities for process improvement. If there are multiple reasons for delay, please include all of these reasons in the record. Because reasons are not currently ranked or prioritised in the submission platform, it is not possible to objectively differentiate them in the analysis. However, providers are welcome (but not required) to indicate which reason or reasons contributed most significantly to the delay. Where there are also multiple sources of delay associated with these reasons, the CTP Team will accept in good faith the source of delay which the provider associates with the most significant reason for delay as long as the rationale is sufficiently explained in the comments.