CRN Central Portfolio Management System Guidance Frequently Asked Questions V. 1 July 2016

Document Control This document is issued and updated by the national Clinical Research Network (CRN) Coordinating Centre. Readers should ensure that the latest version is being viewed.

Document Information

Version

Frequently Asked Questions About The Use Of The NIHR Central Portfolio Management System V.1

Supersedes

None

Function

Research Operations, Research Delivery Directorate

Effective Date

25 July 2016

Audience

Any user of the Central Portfolio Management System

Document Title

Change History Version 1.0

Not applicable in first version

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Contents

SECTION 1: Access SECTION 2: Information available to the public SECTION 3: Commercial Submissions SECTION 4: CPMS study record SECTION 5: Research activity upload SECTION 6: National research delivery team contacts

P4 P6 P9 P14 P16 P19

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SECTION 1: Access 1.1

Who has access to the NIHR Central Portfolio Management System?

The Central Portfolio Management System (CPMS) is an internal management information system for the Clinical Research Network (CRN). It replaced the functionality provided by three internal CRN systems: the UKCRN Portfolio Database, the Industry Application Gateway and the Study Tracker. CPMS role

Who has this role?

National Portfolio Manager (England)

CRN CC Research Delivery team, Support My Study Helpdesk, Business Intelligence teams

National Portfolio Scotland - staff in NHS Research Manager (Scotland / Scotland Wales / Northern Ireland) Wales - staff in Health and Care Research Wales NI - staff from Northern Ireland Clinical Research Network

What functions can this role perform? ● Create study records ● Edit study records with a Lead Country of England ● Approve changes to study records with a Lead Country of England ● Upload recruitment data for studies with a lead Country of England ● Undertake commercial services ● Manage commercial study records resulting from the network commercial services ● Manage non-commercial study records with a Lead Country of England. ● View all study records ● Create study records ● Edit study records for which they are the Lead Country ● Approve changes to study records for which they are the Lead Country ● Upload recruitment data for study records for which they are the Lead Country ● View all study records

Local Portfolio Manager

Core staff within Local CRNs (e.g. Research Delivery Managers, Information Managers, BI Service staff, Industry teams) plus any local staff authorised by Local CRN

● Edit study records for which they are the lead LCRN ● Upload recruitment data ● Undertake commercial services ● View all study records

Company representative

Staff within commercial companies who are responsible for making commercial submissions

● Make a commercial submission for a new study ● View study records they are associated with ● Make additional commercial

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submissions for study records they are associated with Chief Investigator

Study level role

● Edit study records you are associated with ● Upload recruitment data for studies you are associated with

Study Coordinator

Study level role

● Edit study records you are associated with ● Upload recruitment data for studies you are associated with

Recruitment Activity Coordinator

Study level role

● Edit study records you are associated with ● Upload recruitment data for studies you are associated with

Public user

Anyone logging into CPMS without having been assigned one of the CPMS roles above

● ●

●

Make a commercial submission for a new study Cannot view any study information only has access to the CPMS Home Page and the ‘Create a Submission’ page. Once a public user creates a commercial submission their role is updated to a Company representative role on the study they have just created a submission for

Please note : For Study level roles, access to a study record is based on the contact being added to the study record, using the email address provided to the national portfolio team. If you use several email addresses, this might mean that you don’t see studies you know you should be associated with if you use an alternative address to access CPMS. In this case, please contact [email protected] for assistance. Please note: Whist the study team roles (Chief Investigator, Study Coordinator and Recruitment Activity Coordinator) all have identical access in CPMS (they can all perform the same tasks) the different CPMS roles indicate the role an individual plays on the study. In terms of business processes, we contact the Chief Investigator and the Research Activity Coordinator about different things.

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SECTION 2: Information available to the public 2.1

What has replaced the public view of the UKCRN Portfolio Database?

In developing CPMS the CRN Executive and colleagues in the Department of Health jointly agreed that there should be one source of information about clinical research taking place across the UK for patients and the public. CPMS provides information about CRN Portfolio studies to the UK Clinical Trials Gateway (UK CTG). The interface between UK CTG and CPMS ensures that any changes to study records in CPMS are reflected in UK CTG; this update happens weekly. The NIHR CRNs Open Data Platform now has access to CPMS study and recruitment data and is a key tool through which clinical research professionals can access data about CRN Portfolio studies in an analytical tool.

2.2

Are all NIHR CRN Portfolio studies included in UK CTG or just clinical trials?

With the exception of commercial medical device studies and in set-up commercial studies, all CRN Portfolio studies are included in UK CTG, not just clinical trials. There is an option within CPMS for individuals with a study team role to opt out of including their study in UK CTG.

2.3

Is CPMS the only source of data for the UK CTG?

No, UKCTG also draws information from two additional sources; Clinical Trials.gov and ISRCTN.

2.4 My study search in UK CTG appears to be returning duplicate records of the same study, why is this? The UKCTG website explains this - Trials may be listed in more than one of the source registers from which we create our database. This means you could find two records referring to the same trial in your search results. If the information about your study is different in these duplicate records this will have arisen because the source registers (e.g. CPMS or Clinical Trials.gov) contain different information. In order for this to be updated in UK CTG you will need to update the information at source (i.e. within either the CPMS, ClinicalTrials.gov or ISRCTN).

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2.5 I used to be able to view studies that were open to new sites on the public view of the Portfolio Database. Where can I now access this information? This information is captured in CPMS and can be viewed via the NIHR CRN Open Data Platform (ODP) and can easily be found by Local Network staff and provided to interested NHS Organisations and NIHR staff. Alternatively, anyone with an NHS email address can register to use the NIHR CRN Open Data Platform using the ‘login with your email address’ (rather than NIHR login)’ option. CRN: Wessex has produced a guide on how to view studies open to new sites on ODP.

2.6 Where can I find out how a study is progressing towards recruitment to time and target? This information is captured in CPMS and can be viewed via the NIHR CRN Open Data Platform (ODP). Wherever you see a table of studies in Portfolio ODP, you will see the English Recruitment to Time and Target Rating. Alternatively, if you go to the HLO 2 RTT tab, you can browse the Closed Studies and Open Studies tables to find a range of data points that relate to recruitment to time and target for your study. For commercial studies, most NIHR staff are able to access the Commercial Reporting ODP app, where they can find study and site performance figures. Local Network staff are able to provide this information to interested NHS Organisations and NIHR staff. Alternatively, anyone with an NHS email address can register to use the NIHR CRN Open Data Platform using the ‘login with your email address’ (rather than NIHR login)’ option.

2.7

How do I search for a CRN Portfolio study (with a CPMS ID) on UK CTG?

You can search for a CRN Portfolio study on UK CTG by using the CPMS ID in the site search box (NB: this search is case sensitive so ensure that you include CPMS as capital letters and don’t include a space between CPMS and the number). Alternatively, you can use the following link, replacing the highlighted text with the appropriate study ID: https://www.ukctg.nihr.ac.uk/trials?query=%257B%2522query%2522%253A%2522CPMS12 345%2522%257D

2.8 Is the move to have UKCTG as the public view of the NIHR CRN Portfolio a temporary arrangement? No, this was a strategic decision made by the CRN Executive and colleagues at the Department of Health.

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2.9 Are there any plans to amend the UK CTG to include data items that were particularly useful to NHS organisations and local study teams recruiting to CRN Portfolio studies? The CRN is collecting feedback on UK CTG functionality and will provide this to colleagues in NIHR who manage UK CTG for their consideration.

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SECTION 3: Commercial Submissions 3.1 Do I need a Confidentiality Agreement (CDA) in place with the NIHR CRN to submit my study in CPMS for feasibility services? Although you will be able to create a CPMS account and submit a study without a CDA in place, we will be unable to process any requests until one is in place. Therefore, we recommend that all companies new to the NIHR CRN feasibility services contact [email protected] requesting a CDA with us as soon as possible. This will ensure that there will be no delays to your submission being processed by our Feasibility Team. We require the following information to set up the CDA which you can email to [email protected]: ● Full company name and address (Please note: we will include ‘and affiliates’ after your company name unless you request otherwise. This is to avoid the need for setting up separate agreements with different subsidiary/affiliates of your company in the future. We would therefore suggest that you provide the relevant holding company name for the agreement). ● The Registered Company Number ● A list of your company subsidiaries and affiliates so that we can note which companies are covered by this agreement.

3.2

What feasibility service(s) does my study require?

We offer three, free of charge, feasibility services: Early Feedback, Site Identification and Site Intelligence. You can view a detailed overview of these services to decide which are suitable for your study here: https://www.crn.nihr.ac.uk/can-help/life-sciencesindustry/feasibility/ If you would like to discuss which services would be suitable for your study, please don’t hesitate to get in touch with [email protected] for further advice.

3.3

What timelines can I expect for NIHR CRN feasibility services to be completed?

Once you have completed the CPMS application form, the timelines are: Within the same day: ● An email notification to acknowledge the submission of your information Within two working days: ● A call or email back if the Network has any additional questions to ask.

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Service timelines after three working days: ● Early feedback: Complete information will be sent to you within a maximum of 10 working days of submitting your request with the necessary study details. ● Site intelligence: Tailored site intelligence information and further recommendations sent to you within 15 working days of submitting your request with necessary study details. ● Site identification: Recommendation of sites and targets including supporting data on performance history etc. sent to you within 15 working days of submitting your request with the necessary study details.

3.4 Can I answer ‘refer to the protocol attached’ instead of filling out all the details of the questions within the CPMS application? No, we require complete answers to all questions that are asked because the protocol is not shared with all those involved with delivering your feasibility services.

3.5 As commercially sensitive information is requested in the submission, what documents and parts of the submission will be shared with local networks and potential sites? Only the information that you have inputted into Part B of your submission will be shared with the sites. Part A is completely confidential. If you have selected ‘Yes’ to QB21 in your submission and uploaded a separate Schedule of Events to the ‘attachments’ section, then this document will be shared with the sites. Also, feasibility questionnaires can be shared with/completed by sites at your request (if uploaded to the attachments section). Please note: that we do not share any part of the protocol with sites and so a separate Schedule of Events should be uploaded, if available.

3.6

What documents do I have to attach to my submission?

As a minimum we require the most recent version of your protocol/ synopsis. If available, please also provide a separate attachment of your Schedule of Events with all confidential information removed. This is so that this document can be shared with sites without the protocol who you may not yet have a CDA in place with. If you would like us to circulate your own company feasibility forms to sites alongside our forms, please attach these to your submission. Please feel free to attach any further feasibility documentation that you feel would be useful for us. As a standard practice we never share non-blinded information that you have provided us with, if as an exception you would like us to, please inform us at Question B26.

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3.7

Why can’t I attach the completed Site Intelligence template at Question B21?

This could be down to a number of reasons, please check that all of the following are removed/added to your spreadsheet and that you are using the template provided in QB24. ● Remove all hyperlinks in email ● Remove any characters in phone number ● Please select options from the drop down list in columns F and I ● If any information is unknown, please input ‘Null’ into vacant cells ● Ensure site names do not have any characters and names are kept to a minimum

3.8 Why have I received a notification from CPMS saying that my study has been reverted? There are a number of reasons why your submission may be reverted. Common reasons include: ● No CDA appears to be in place with your organisation and the NIHR CRN. ● There are questions about whether the services selected are suitable for the stage of your study. ● There are attachments missing (e.g. no protocol or Schedule of Events - if said to be available at question B21) or attachments that have errors (e.g. password protected). ● You have selected Site Intelligence but no Site Intelligence template has been added to question B24 (this is essential). ● There are answers referring to the protocol rather than being copied in full from the protocol into the submission. ● Potential errors with Trial Management dates (question B33) and/ or Recruitment Targets (questions B34-39). If your study is reverted, you will receive an email from our national Feasibility Team detailing the reason for your reversion and how to resolve this issue so that your submission can be processed. Contact details will also be provided if you have any further questions or if you’re having difficulties resolving the issues addressed.

3.9 Where can I find my completed feasibility forms once services have been completed? Once the service is completed you will receive an email to notify you, you can then log into your submission and the feedback will be available to download from the ‘response and attachments’ section. See example below.

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3.10

Is it possible to request further NIHR CRN feasibility services?

Yes, you can do this by going into the ‘Study Submissions’ tab on the left hand side of the CPMS homepage and then clicking ‘ADD SUBMISSION TO SELECTED STUDY’ as seen below. This will enable you to add the service that you require to your submission.

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3.11 How do I withdraw a request for NIHR CRN feasibility services once I have already submitted my study? Please email [email protected] with the submission details and reasons for withdrawal and it will be facilitated from there.

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SECTION 4: CPMS study record 4.1

How is a study record created in CPMS?

For non-commercial studies, once a study has been confirmed as eligible for CRN Support, the national Research Delivery team will create a record for the study in CPMS. For commercial studies, a skeleton’ study record is created when a company submits for feasibility services. The commercial study record is completed by the national Research Delivery team once the study has been confirmed as eligible and feasible.

4.2

How are commercial study records maintained?

Commercial study records are maintained and updated by the national Research Delivery team. The team uses information from the company feasibility submission and ongoing updates from the company and via LCRNs (via the RAG notes monthly process) to ensure the record is kept up to date.

4.3

How are non-commercial study records maintained?

Non-Commercial study teams are responsible for maintaining their own study records however both the Lead local CRN and the national Research Delivery team are able to support this. Changes to key data items within the study record require approval by the national Divisional Research Delivery team before they appear in the live study record. You will be notified of this when making these changes. While the changes are pending approval, you will be able to view the changes pending, but will not be able to further edit the study record. Once the changes are approved, the record will become editable again, and a note will be added in the notes tab to indicate the change has occurred.

4.4

Where can I find the CPMS data definitions?

A CPMS Data Definitions Document is in development and will shortly be available on the CRN website.

4.5

What documents should be stored on the attachments tab in the study record?

During the eligibility review of a non-commercial study, the study protocol and grant award letters used for this review will be uploaded to the attachments tab in the study record by the Portfolio Eligibility Team.

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Some amendments to study records will require evidence to support the change e.g. amended versions of a protocol and/or new grant award letters. It is recommended that study teams or Local Network staff upload these to CPMS when changing key data items. The Lead LCRN and national Research Delivery team also have the facility to upload documents to the attachments tab, and it is recommended that this is used for documents relating to study delivery e.g. Performance Review Plan.

4.6 I have noticed an error in a study record I have no edit rights to, how do I get it corrected? Please contact the relevant national Research Delivery team (see section 6 for contact details.

4.7 How can I update study team details (e.g. Chief Investigator, Research Activity Co-ordinator)? If you need to update the individuals associated with a study, please contact the relevant national research delivery team who will process your request. (see section 6 for contact details). Please note that in order to add a new contact we will require the full name, email address and postal address for the contact (if they do not currently have a CPMS user account), as well as confirmation from the Chief Investigator for the study.

4.8

How do I apply for ISTCRN Registration via CPMS?

Instructions for applying for an ISRCTN are available on the CPMS User Guides page.

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SECTION 5: Research activity upload 5.1

Where do I find the research activity upload spreadsheet?

The research activity upload spreadsheet can be found on the CRN website or within the Research Activity pages on CPMS. This can be found using the navigation panel on the left hand side of the screen. You can also download a spreadsheet specific to your study, including all data uploaded so far, on the Studies section of CPMS. You can do this from the Design tab (in edit mode) using the blue text "Download all research activity for this study", under the heading Research Activity. This spreadsheet also includes a line for every site on the study record where research activity has not yet been reported. This can be used as an easy reference to populate the correct site information for your upload. Please note that there is no longer a requirement for you to upload all previous activity as well as new data, you can simply upload new research activity that has occurred since the last upload. 5.2 Who is responsible for uploading research activity data for non-commercial studies? Anyone with a study team role in CPMS (i.e. Chief Investigator, Study Coordinator or Research Activity Coordinator) are able to upload recruitment data. However it is the Research Activity Coordinator who has overall responsibility for this key monthly task, and who will be the first point of contact if there are any queries about this data.

5.3 Where do I find guidance on how to upload my non-commercial research activity data into CPMS? Our how to upload recruitment data guide provides step by step instructions and is available on the CRN website and via CRN Learn. If you have any difficulties uploading your research activity data and have already consulted the guidance, please contact the Study Support Service Helpdesk either by email to [email protected] or by calling 0113 343 4555.

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5.4

How do I record that there was no recruitment into my study this month?

Our how to report no new research activity guide provides step by step instructions and is available on the CRN website and CRN Learn.

5.5 The recruitment data already present in CPMS for my study is incorrect how do I correct this? If you discover any errors in your recruitment data that have been uploaded to CPMS, the national Research Delivery team can correct this. This can only be done by a complete delete of current data and re-uploading the entire data set including any corrections. You will be required to provide the corrected complete new data set before a delete is performed. Contacts for the relevant national research delivery team are provided in section 6.

5.6 As an Research Activity Coordinator (RAC), each month I used to get an email from the UKCRN Portfolio Database reminding me it was time to upload recruitment. Is this replicated in CPMS? No, CPMS doesn’t currently send recruitment reminders. Your lead Local Clinical Research Network (LCRN) will work with you to support your uploads of recruitment data.

5.7

How is commercial data uploaded?

Commercial data is currently provided by the company contact (Sponsor or managing CRO) on a per site/per study basis, monthly, to the national commercial research delivery team. The national team then upload the data to CPMS on behalf of the company.

5.8

My upload keeps failing, how can I get help?

There are a few common reasons why uploads fail. A troubleshooting guide for study teams is in development, in the meantime, please send your data file to the relevant national research delivery team and they will assist you with the upload. Contacts for the relevant national research delivery team are provided in section 6.

5.9 We have decided to change the format of participant IDs for our study, can we just use the new IDs in our next upload? When you change participant IDs which have already been uploaded, CPMS is unable to recognise the change and will log both the old and new IDs. In order to avoid this duplication the national research delivery team will need to remove all of the existing data on CPMS and replace it with a complete set of the correct data. Please therefore forward a copy of the corrected data, including all of your recruitment to date for your study, to the relevant national

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research delivery team. Contacts for the relevant national research delivery team are provided in section 6.

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SECTION 6: National research delivery team contacts

Lead Country

Study Type

Specialty

Email address

England

Non-commercial

Cancer

[email protected]

Diabetes Stroke Cardiovascular disease Metabolic and endocrine Renal disorders Dementias and neurodegeneration Mental health Neurological disorders England

Non-commercial

Children

[email protected]

Genetics Hematology Reproductive health and childbirth Primary care Ageing Health service and delivery Oral and dental Public health

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Musculoskeletal Dermatology Anesthesia /perioperative medicine and pain management Critical care Injuries and emergencies Surgery ENT Infectious diseases / microbiology Ophthalmology Respiratory disorders Gastroenterology Hepatology England

Commercial

All

[email protected]

Scotland

All

All

nicola [email protected]

Wales

All

All

[email protected]

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