NHS REC Booking & Submission Changes Spring 2014
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1 EoSRES Research Ethics Service NHS REC Booking & Submission Changes Spring /05/2014/EoSRES /CYA
2 Applying for an NHS REC review Improved service Booking and application more straight forward 22/05/2014/ EoSRES/CYA
3 NEW Central Booking Service (CBS) New single number: Cover all bookings for RECs in the UK Replaces existing Central, Proportionate Review (PR) and Local Allocation Systems 22/05/2014/EoSRES/CYA
4 More efficient allocation of applications across meetings You can still book the REC of your choice for full applications using CBS 22/05/2014 EoSRES /CYA
5 CBS Opening hours: 9.30am 4.00pm Monday to Friday If lines are busy, or you call outside these hours, you will be able to leave a voic requesting a call back. 22/05/2014/ EoSRES/CYA
6 During the call you will need to:- Provide your IRAS Project ID Answer a series of questions about your study Confirm that you are ready to submit on the same day. 22/05/2014/ EoSRES/CYA
7 This will enable to the operator to check that your study is ready for review, that you are booked to an appropriate REC and that electronic submission is enabled in IRAS. When booking, you will be offered the first available agenda slot within the UK. You may, however, request review by a named committee, but if you choose this option the 60-day clock will start from the submission date for the REC and not the date of application receipt. 22/05/2014/ EoSRES/CYA
8 Electronic submission must be completed on the same day as the booking is made You must ensure that your application is ready to submit (i.e. form checked, supporting documents attached and e-authorisations in place) before calling to book your application 22/05/2014/EoSRES/CYA
9 After the call: You will receive an confirming your booking and REC reference number You will need to insert your REC reference number on to your IRAS form before electronically submitting your application on the day of your booking 22/05/2014/ EoSRES/CYA
10 Mandatory electronic authorisation for declarations on NHS REC forms From 28 April 2014 all forms created in IRAS for submission to NHS RECs must be authorised using the electronic authorisation (e-authorisations) functionality in IRAS 22/05/2014/EoSRES/CYA
11 To electronically authorise an application, you must have an IRAS account If you don t have an account, please set one up as soon as possible E-authorisation must be completed in advance of booking a REC 22/05/2014/EoSRES/CYA
12 NEW introduction of electronic submission to NHS RECs All forms created in IRAS for submission to NHS RECs will be submitted electronically from IRAS You will not need to submit hard copies 22/05/2014/EoSRES/CYA
13 The NHS REC form (including GTAC, Social Care REC, Research Tissue Bank and Research Database variants) and non-nhs Site Specific Information (SSI) forms and their associated supporting documentation will be electronically submitted by the applicant from IRAS to the REC system 22/05/2014/EoSRES/CYA
14 Applications processed via the Proportionate Review Service will automatically be booked to the next available agenda slot in the UK. 22/05/2014/ EoSRES/CYA
15 Any pre-submission advice should continue to be sought from EoSRES 22/05/2014/ EoSRES/CYA
16 Notice of Substantial Amendment (NOSA) forms Still created in IRAS but not submitted electronically at this time Submission will continue via If you submitted your original application using the NRES on-line form or under earlier procedures, you will need to create a minimal dataset in IRAS in order to generate an amendment form. 22/05/2014/ EoSRES/CYA
17 Minimal Dataset Forms At present there is a system error in enabling of the electronic authorisations functionality for the Chief Investigator declaration on NOSA forms generated for minimal dataset projects in IRAS. Therefore. CI declaration in NOSA forms generated for minimal dataset studies in IRAS will be exempt from the recently introduced mandatory requirement for electronic authorisation until this system error has been fixed 22/05/2014/EoSRES/CYA
18 Assistance From the EoSRES Co-ordinators: Lorraine: (from NHS ext: ; Uni ext:83878) Diane: (from NHS ext: ; Uni ext:83871) Arlene: (from NHS ext: ; Uni ext:83848) 22/05/2014/ EoSRES/CYA
19 Further guidance. Overall summary info about changes and links to other guidance docs: - includes a step by step guide to new booking/submission processes. Guidance is also provided on the E-submission tabs for REC forms in IRAS. 22/05/2014/ EoSRES/CYA
20 Uploading documents to checklists in IRAS refer to hlpdocumentstorage.aspx IRAS electronic authorisation functionality refer to hlpsignatures.aspx 22/05/2014/ EoSRES /CYA
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