Trust/Host Site Approval. Presented by: Anika Kadchha Research Governance Officer

Transcription

1 Trust/Host Site Approval Presented by: Anika Kadchha Research Governance Officer Joint Research & Enterprise Office Training 19 th January

2 Outline What is Research NHS Ethics (if required) Host Site Approval (Trust Approval) Audit NIHR and Targets Joint Research & Enterprise Office Training th January2014

3 Defining Research The primary aim of research is to derive generalizable new knowledge. Addresses clearly defined questions, aims and objectives. May involve randomisation. Joint Research & Enterprise Office Training th January2014

4 Service Evaluation or Clinical Audit? Service Evaluation Designed and conducted solely to define or judge current care Requires Department Lead permission (CGL) Clinical Audit Designed and conducted to produce information to inform delivery of best care Requires Clinical Audit Manager s review - [email protected] Contact Clinical Research Governance Manager Joint Research & Enterprise Office Training th January2014

5 Research Not Requiring REC Review Involving previously collected, non-identifiable information Involving previously collected, non-identifiable tissue samples Involving acellular material Involving NHS staff Please read the guidance carefully and consult the JREO Even if your study does not require REC review, it is likely it will still need R&D approval Does my project require REC review? Joint Research & Enterprise Office Training 23 January 2014 Joint Research & Enterprise Office Training 19 th January

6 Host Site Approval Host Site Approval (Trust approval) must be given by each R&D office, at each NHS organisation where the study is due to start. This approval is in addition to the approval from the NHS REC Trust approval is mandatory for all research being undertaken on SGHT premises or involving SGHT participants Joint Research & Enterprise Office Training th January2014

7 Required Documents IRAS R&D form Final signed version IRAS Site Specific Information Form (SSI) Final signed version REC Favourable opinion letter (including provisional opinion and all correspondence) Final REC approved version of the Protocol Final REC approved version of the Patient Information Sheet and Informed Consent Form Study Specific documentation as approved by the REC CVs of all the members of the research team Signed and dated Good Clinical Practice (GCP) certificate if a CTIMP Research Passports (if required) Signature form from the Care Group Lead and Business Manager ** NEW** Joint Research & Enterprise Office Training th January2014v

8 Required Documents (continued) Evidence of insurance (if applicable) Evidence of funding (if applicable) Certificate of ARSAC (if applicable) MHRA CTA approval (if applicable) Any other approval documentation that is relevant to the study (CAG approval, GTAC etc.) Confirmation of REC approval for any Substantial Amendments (if applicable) Confirmation of authorisation from MHRA for any Substantial Amendments Joint Research & Enterprise Office Training th January2014

9 Support Department Services Approval is required if you require any support department services for any above routine care procedures Radiology approval is required irrespective of whether above routine Contacts Radiology - Mark O'Leary (Mark.O'[email protected]) ext 0383 Pathology - Derek Haswell ([email protected]) Pharmacy Geoffrey Howell ([email protected]) Joint Research & Enterprise Office Training th January2014

10 Amendments Substantial An amendment to the protocol or any other supporting documentation that is likely to affect to a significant degree the: 1. Safety or physical or mental integrity of the trial subjects 2. Scientific value of the trial 3. Conduct or management of the trial Non-substantial Requires notification only (e.g. typos, amending members of research teams except CI & PIs) Amendment forms generated in IRAS Inform Sponsor and Trust R&D REC has 35 days to respond Trust R&D must also approve Joint Research & Enterprise Office Training stth November January

11 Top Tips for getting your study through on time Ensure you have discussed your study with the relevant departments in advance Double check your ethics approval letter for the correct versions and dates Ensure the document set is complete Use the model agreement Timelines are important Feasibility is key! Joint Research & Enterprise Office Training stth November January

12 Progress Reports, Declaration of End of Study and Final Report Annual progress reports to REC Anniversary of REC approval Until end of study Declaration of End of Study to REC Appropriate form within 90 days of the end of the study Or within 15 days if the study is terminated early Final report on the research to REC Within 12 months of the end of the study No standard format required (but JREO can provide template) Copy all reports to the Sponsor and all R&D departments involved in the study Joint Research Alerts & for Enterprise these. Office Training stth November January

13 Audits Purpose: To evaluate trial conduct and compliance with the protocol, SOPs, GCP and the applicable regulatory requirements Condition of Trust approval is to allow audit of your study. Triggered versus routine. Refusal to be audited will result in your study being referred to the Research Governance Committee and possible withdrawal of your trust approval. ICH GCP Section 5.19 Joint Research & Enterprise Office Training 23 January 2014 Joint Research & Enterprise Office Training 19 th January

14 CSP Studies System used for National Institute of Health Research (NIHR) If your study is fully funded you must apply. Funds must be awarded in open competition for investigator led study. If not accepted for portfolio adoption does not affect your project. If unsure contact the Joint Research and Enterprise Office! Joint Research & Enterprise Office Training th January2014

15 Research Passports Check the algorithm Allows Trusts to issue honorary research contracts (HRCs) or letters of access (LoA) to HEI researchers who need to undertake their research within the NHS. The research passport provides evidence of the pre-engagement checks undertaken on the researcher in line with NHS Employment Check Standards; and NHS to NHS arrangements for sharing and accepting pre-engagement checks between NHS organisations when NHS staff wish to undertake research within the NHS outside of their employing Trust. Read our SOP! Joint Research & Enterprise Office Training th January2014

16 15 Day Target R&D offices have 15 (calendar) days to give Host site /trust approval. Clock starts on receipt of a valid application We aim for this whether the study is CSP or not Oct, Nov, Dec 79% of all studies opened at GHT meet this target. Joint Research & Enterprise Office Training th January2014

17 70 Day Target Investigators have 70 (calendar) days to recruit their first patient/participant into the study Clock starts on receipt of a valid application Clock can not stop. We aim for this whether the study is CSP/NIHR or not FPFV card 70 Day reminder on day 70 Joint Research & Enterprise Office Training th January2014

18 Upcoming Workshops February Data Management 17 February March April Monitoring (for non CTIMP studies) Safety Reporting 24 March 28 April Board Room H2.6 Hunter Wing JB 1, Jenner Basement Board Room H2.6 Hunter Wing 12:30 12:30 12:30 Joint Research & Enterprise Office Training th January2014

19 Useful Information HRA SGUL SOPs R&D Forum IRAS - Joint Research & Enterprise Office Training th January January2014

20 Questions? Joint Research & Enterprise Office Training 23 January 2014