Frequently asked questions
FOR RESEARCHERS
FOR RM&G STAFF SOFTWARE QUERIES
FAQS FOR RESEARCHERS Q. As a researcher, how will I access NIHR CSP? A. Studies enter NIHR CSP through the
Integrated Research Application System (IRAS). If a study is being conducted in England and has a lead R&D office in England you should indicate that you wish to apply for NHS permission through NIHR CSP when you are filling in your information in IRAS. You should continue to liaise with your R&D Office at the earliest opportunity in the approval process to ensure they are aware of the study and can offer you support. Currently, NIHR CSP is only used for
NIHR Portfolio Studies.
Q. What information do I need to submit to apply to NIHR CSP?
A. If you have a
potentially eligible study and apply for permission through NIHR CSP you will be required to fill in a CSP Application Form which will be generated through IRAS. This takes information from IRAS and, additionally, asks you for information which will allow the NIHR CRN CC Portfolio Team to assess whether your study is eligible, potentially eligible or ineligible for adoption onto the NIHR Clinical Research Network Portfolio. Only those studies which are potentially eligible or eligible will initially be processed through NIHR CSP. The information you provide will be accessed by staff in the CSPU, CLRNs and local Trusts, and will be used for governance checks and monitoring.
Q. How will I know if my study is likely to be eligible or potentially eligible for the NIHR Portfolio? A. In England, the Department of Health has determined that studies (clinical trials and other well designed studies which involve the NHS) that are funded by NIHR, other areas of Government, and NIHR non-commercial Partners are automatically eligible to be included in the Portfolio. NIHR Partners are those organisations that:
- award research funds as a result of open competition across England with high quality peer review
- fund research that is of clear value to the NHS
- take account of DH and NHS priorities and needs in their research funding strategies.
In addition other studies, such as commercially sponsored studies or those with industry funding which are led by an academic investigator, may be considered for inclusion in the Portfolio by undergoing an adoption process.
Full details are included in the NIHR eligibility paper, available to download from this website.
Q. What if my study is not eligible for the NIHR Portfolio, how do I apply for NHS Permission?
A. You should contact the R&D Office which manages research for each NHS organisation involved in the study. Contact details for NHS organisations are given on the
NHS R&D Forum website. If your study was identified as potentially eligible during the initial stages of NIHR CSP, but subsequently identified as non-portfolio, then any governance checks already carried out will be passed on to the Trust to avoid duplication of work.
Q. What happens once I’ve submitted my CSP Application Form through IRAS?
A. When you submit your CSP Application Form through IRAS, the status of the submission is updated within the submission tab. If your study is identified by the portfolio team to be ineligible for adoption, an alert will be created and you will not be able to submit subsequent forms to NIHR CSP.
If your study is eligible or potentially eligible for adoption, you will get notification, within the submission tab, that the study is pending at the CSP Unit (CSPU). Once the study has been added to the NIHR CSP database by CSPU, the pending status will change to
Accepted. This will mean that any subsequent changes to the form from this point would need to be submitted as an amendment. The R&D form, and SSI forms generated from this, will be enabled for submission through NIHR CSP.
Q. How can I check the progress of my study? A. An automatic status update will be sent to the record within the form’s submission tab once the form has been received by CSPU. There are three other notifications that you will receive during the NIHR CSP process:
- Validation of R&D form
- Validation of SSI form
- First site sign off
Confirmation of portfolio adoption will still be received through
the portfolio team. An approval letter indemnifying the study and granting NHS permission will still be sent directly from the NHS organisation.
Q. How will I know when my study has gained NHS Permission? A. If you are the Chief Investigator, you will be contacted when the first site has received sign off. This does not mean that you can start the study, but just confirms that the governance checks have been carried out and that a governance report has been generated in order to gain NHS permission. Whether you are a CI or PI, you must not commence any research activity until you have received formal notification of approval from each NHS organisation.
Q. Does NIHR CSP sign off mean that I can start my study? A. No. NIHR CSP sign off means that all the governance checks for your study have been performed and a governance report has been issued to the NHS organisation whose approval is required. The study can only start when the NHS organisation has given approval and you have received formal notification. The NHS organisation will still be responsible for sending the notification of actual NHS permission directly to the Chief Investigator.
Q. Approximately how long will it take from the time I submit my CSP Application Form through IRAS to gaining NHS Permission to start my study? A. This will depend on a number of variables; study type, regulatory approvals and agreements required, speed of response from researchers etc. Once all governance checks have been completed, each
Comprehensive Local Research Network (CLRN) will work with the Trusts involved in the study in order to gain NHS permission at each site. There is no time target for governance checks due to the number of variables, however NHS permission must be approved or declined within 21 days of the completion of the governance checks.
Q. I submitted my study to NIHR CSP through IRAS, but I have been informed that it is not eligible for the NIHR CRN Portfolio. What should I do next?
A. To continue with your application for R&D approval through your local R&D Office, please return to IRAS and select the
Project Filter link, found at the top of the left-hand menu. Scroll down to Question 5a and click
No, and then click the
Navigate button at the bottom of the page; the CSP Application Form is removed from the Project Forms list. For instructions on how to proceed, please refer to the notes in on the Submission tab in IRAS, in the NHS/HSC R&D Form area.
FAQS FOR RM&G STAFF Q. Will each NHS organisation have to pay an annual licence fee for CSP ReDA? A. There will be no annual licence fee - user accounts will be established for each organisation under a CLRN site licence which will be funded by NIHR.
Q. Will R&D departments be expected to transfer from EPS to ReDA? Will data have to be entered twice by RM&G staff? A. At this stage, organisations are not advised to change their current arrangements. CSP ReDA is a different system to the ReDA package and is purely designed for the process of NIHR CSP only. It does not have the capability to manage the study once it has been initiated.
Trusts must maintain their own database to record all research activity in line with the Research Governance Framework, whether portfolio or non-portfolio. As part of the IRAS submission, a .xml document will be generated and Trusts can request this from the researchers. Once uploaded, this will auto-populate a number of fields in both the EPS and ReDA databases, although local information (start dates, etc) will still need to be added.
Q. Will the NIHR CRN CC and CLRNs be legally liable for studies? A. Neither the Coordinating Centre nor CLRNs can be legally liable for studies as they are not legal entities. Legal liability rests with the NHS organisations and a researcher will not have indemnity under HSG 96 (48) until they receive formal notification of approval.
Q. How do NHS organisations interact with NIHR CSP? A. NHS organisations are member organisations of their local CLRN and as such will be involved in the NIHR CSP process for studies which they are being asked to host, for example in providing local authorisations from pharmacy or other support departments. Once a study has passed through NIHR CSP, an authorised individual within the NHS organisation will be presented with a governance report listing the outcome of all governance checks that have been undertaken with regard to the study. The decision whether or not to host the study always rests with the NHS organisation.
Q. Will NIHR CSP satisfy the Health Care Commission’s C12 return? A. The Healthcare Commission is being invited to view NIHR CSP Operating Procedures and CSP ReDA software to identify whether it meets the HC’s C12 return. Once this is confirmed, a letter of endorsement will be added to the NIHR CSP website and circulated to all Lead RM&G Managers. Trusts should still ensure that they fulfil all other elements of C12 and complete their returns in line with local policy.
Q. How can NHS organisations be assured that NIHR CSP will satisfy regulatory bodies such as the MHRA? A. The MHRA is being invited to view NIHR CSP Operating Procedures and CSP ReDA software to ensure it satisfies their requirements. Once this is confirmed, a letter of endorsement will be added to the NIHR CSP website and circulated to all Lead RM&G Managers.
Q. How will protocol amendments be handled by NIHR CSP? A. This is still being agreed. An Amendments Sub Group has been created as part of the Systems and Processes Definition Group and is currently considering and reviewing possible handling for submissions and processing of amendments. This process will then be integrated into the NIHR CSP Operating Procedures.
Q. How will documents (e.g. protocols, PIS etc) move through the NIHR CSP process?
A. IRAS does not have the capability of handling documentation to support of a submission. This will need to be supplied to the
Lead CLRN or the local CLRN via email (depending on study type). Approval letters from regulatory bodies and other documentation required for the research governance review of the study should be sent to the Lead CLRN (whom the CI should be in contact with) as soon as received. This will aid CSPU to process the study as fast as possible. R&D Forms should be sent to the Lead CLRN; SSI Forms should be sent to the local CLRN.
Q. If the CLRNs do no need to start the clocks for a study until the SSI Form has been received, what happens if the researcher does not need to submit an SSI Form because the project is Site Specific Exempt? A. The local clock should start on receipt of the SSI Form as this is when the information for the local R&D is supplied. If a study is site specific exempt, then a PI (on behalf of the CI) should still be completing the SSI form for NHS permission.
SOFTWARE FAQS Q. What is the different between a licence and a user account? A. Licences cover a specific site. There are 25 licences (one for each CLRN) plus one NIHR CRN CC licence. User accounts are allocated to named individuals and there is a limit to the number available. Each licence will cover a certain number of user accounts (dependent on the CLRN).
Q. What is meant by the term ‘Super User’?
A. A Super User is a user account which has administrative rights to allocate other users that fall under a licence. There will be one Super User per licence (i.e. one Super User will be identified per CLRN). Only Super Users will be able to access the CSP ReDA helpdesk function.
Q. Can studies be monitored and audited using CSP ReDA? A. No, CSP ReDA is solely for managing the process of gaining NHS Permission and not for subsequent management of the study. Each organisation should maintain their own database.
Q. Researchers often get third parties to complete SSI forms on their behalf. Can they still do this when their study goes through NIHR CSP?
A. Yes, although it is always important that the investigators are fully aware of what is being done on their behalf.
Q. If a researcher puts a potentially eligible study through NIHR CSP, but gets turned down for funding at the first attempt, what should they do if they then secure funding through a different eligible funding stream? A. The CI will have already filled out a CSP Application Form and the study will be on the system. In order to prevent duplicate applications, the CI should inform CSPU that funding for the study has been secured from an alternative source, and they will have to submit an additional CSP Application Form.
Last updated: 26 October 2009
Home
About us
Contact us
Library
Login
Print friendly page