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Introduction to the CSP Module

10 October 2011 – NIHR TMN Annual Meeting RIBA ‐ LondonRIBA London

Tomasz KurdzielL d RM&G WYCLRNLead RM&G – WYCLRN

Agenda

•Introduction to the CSP Module

•CSP Process overview & staged implementation

•New features in IRAS

National Institute for Health Research 2

What is the CSP Module

•The NIHR CSP Module is a new web‐based application which supports the CSP process It is built on the Oracle WebCentersupports the CSP process. It is built on the Oracle WebCenter platform and replaces CSP ReDA

•Access to the new system will initially be provided to existing users of CSP ReDA which will eventually be phased out once the

CSP M d l i t bli h dnew CSP Module is established

•The CSP Module is one part of the Research and DevelopmentThe CSP Module is one part of the Research and Development Management Information System (RDMIS) which is currently being developed by the NIHR IS Function in order to support information management across all parts of the NIHR


CSP Module Release 1.0

•CSP Module will replace CSP ReDA and the CSP Tracker held at the CSP Unitthe CSP Unit

•It will include systems for the following processes–Portfolio Eligibilityg y–Validate R&D submissions–Perform Study Wide Governance–QC Study Wide Governance–Validate SSI Submissions–Perform Local Governance (site and/or PIC)–Perform Local Governance (site and/or PIC)–QC Local Governance (optional)–Grant NHS Permission–Process Amendments–Reporting


CSP Module – Task View


CSP Module – Document View


CSP Module – Document View

•Documents will be divided into Levels• Study WideStudy Wide• Local

E h L l ill b di id d i t C t i•Each Level will be divided into Categories

•Each Category will be divided into Document typesEach Category will be divided into Document types

•Mirrors the IRAS checklist

•Documents coming in from IRAS will be automatically uploaded


CSP Module – Study View (CLRN)


CSP Module – Study View (NHS)


CSP Module ‐ Notifications

•When certain tasks are complete, an email notification is sent to inform the researcherinform the researcher

•When a certain stage of the process is completed a new task will automatically appear


CSP Module – PICs

•Participant Identification Centre (PIC) review will now be allocated and undertaken in the same way as local research siteallocated and undertaken in the same way as local research site (SSIF) governance

•The governance review criteria reflect that it is a PIC – but some reviews may be Not Applicable (see CSP Operating Manual for id )guidance)

•PICs are listed in Part C of the R&D FormPICs are listed in Part C of the R&D Form


CSP Process overview & CS ocess o e e &implementation

Create Project in IRASSubmit PAF in IRAS

1. Validate PAF

2 Perform Potential

Submit R&D Application

2. Perform Potential Portfolio Eligibility

3. Assign RAF

Submit SSI Application4. Validate R&D Submission

6.Allocate study-wide Governance Reviewers

& QCs9. Validate SSI

Submission

5. Confirm Portfolio Eligibility

7. Perform study wide governance

10. Allocate local Governance

Reviewers and QCs

8. Perform study wide QC

12. Perform local QC

11. Perform local governance

National Institute for Health Research

(optional)

13. Grant NHS Permission

Staged Implementation

• All new projects created in IRAS (v3.3) from the evening of 18th July 2011 will be submitted electronically from IRAS into CSPJuly 2011 will be submitted electronically from IRAS into CSP Module (e.g. R&D Form and study documents uploaded onto the R&D Form IRAS checklist))

• All projects already created in IRAS (v3.2 and earlier) prior to 18thJuly 2011 will be able to submit the Portfolio Application Form (PAF), R&D Form and Site Specific Information Form (SSIF) electronically from IRAS into CSP Module Supporting studyelectronically from IRAS into CSP Module. Supporting study documents, as per the IRAS check list will need to be sent by e‐mail to the Lead CLRN at the time of submission of the forms

• Migration of studies from CSP ReDA to CSP Module being d k


undertaken

14

Amendments

• The investigator submits amendments by attaching the amendment documents to the R&D Form Document Checklistamendment documents to the R&D Form Document Checklist and resubmitting from the R&D submission tab (exact process tbc)

• The CSP Module detects that an Amendment has been submitted d th A d t V lid ti t k i t t th A d tand the Amendment Validation task is sent to the Amendment

Validator at the Lead CLRN who validates the amendment and completes the Amendment Summary Form and uploads tocompletes the Amendment Summary Form and uploads to document store

• Once the Amendment has been validated an Amendment Review task is allocated to Amendment Reviewers at each site


Amendments

• Substantial / Non –substantial amendments are handled the same way within CSPway within CSP

• Amendment related documentation (notice of amendment form, covering

letter, revised study documents [clean and tracked changes]) sent to Lead CLRN at same time as to REC / MHRA

• The sponsor can implement the amendment on an R&D level, within 35 days of the Lead CLRN confirmation the amendment iswithin 35 days of the Lead CLRN confirmation the amendment is valid subject to the following:(1) regulatory approval is in place( )(2) letter of no objection has been received from the site

• CI / Sponsor provides amendment information / documents to PIs


CI / Sponsor provides amendment information / documents to PIs

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Amendments

• As part of the amendment review, R&D assess:(1) resource (local research team) required to support the amended study(1) resource (local research team) required to support the amended study(2) impact on support departments(3) financial implication of the amended study(4) requirement for new site agreement / financial contract(4) requirement for new site agreement / financial contract

• R&D can provide written Continuing NHS Permission either before or after the 35 day period

S f t l t d d t b i l t d ith i di t• Safety related amendments can be implemented with immediate effect. Formal letter from the CI / Sponsor should support this as part of the document setpart of the document set

• Regulatory approval sent to Lead CLRN once received


New Features in IRASe eatu es S

New Features in IRAS

At the same time as CSP Module went live, new features were introduced to IRASintroduced to IRAS•CSP Application Form now called Portfolio Application Form•Filter Q5 has changedFilter Q5 has changed

o5a asks about BRU, BRC funding (Yes = processed through CSP but no PAF needed)

o5b asks do you want to apply for Portfolio (Yes = PAF needed to apply to Portfolio)

• English sites and PICs on Part C are selected from standard lists• English sites and PICs on Part C are selected from standard lists, and SSI Forms created from Part C

• Uploading documents to IRAS checklist for electronic submissionp g• Draft R&D and SSI Applications can optionally be submitted


IRAS Filter Question 5a + 5b


Selecting sites in Part C


Uploading Documents


Draft Applications


Thank you – any questions?a you a y quest o s?