Content Index - Integrated Dataset

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PART A - Core study information

1. Administrative details

   IRAS question number	Reference in NRES application form or other source	Subject
   A1	A1	Title of research
   A2-1	A70	Student project details
   A2-2	None	CI for student project
   A3	A2	Chief Investigator details
   A4	None	Central study co-ordinator details
   A5-1	A65	Research reference numbers
   A5-2	None	Other linked studies or applications




2. Overview

   IRAS question number	Reference in NRES application form or other source	Subject
   A6-1	None	Lay summary
   A6-2	A68	Overview of study purpose and design




3. Purpose and design

   IRAS question number	Reference in NRES application form or other source	Subject
   A7	None	Methodology description
   A8	A5	Type of CTIMP
   A9	A5a	Phase of CTIMP
   A10	A7	Principal research question/ objective
   A11	A8	Secondary research question/objective
   A12	A9	Scientific justification
   A13	A10-1	Summary of design and methodology
   A14-1	A10-1	Patient/public involvement
   A14-2	NIGB form	Consulting patients/public on use of data without consent




4. Risks and ethical issues

   Research participants
   
   

   IRAS question number	Reference in NRES application form or other source	Subject
   A15	None	Sample group or cohort
   A16	A5c	First time in humans?
   A17	A22/A23	Inclusion/ exclusion criteria

   
   Research procedures, risks and benefits
   
   

   IRAS question number	Reference in NRES application form or other source	Subject
   A18	A13	Details of non-clinical interventions or procedures
   A19	A12	Details of clinical interventions or procedures
   A20	A11	Withholding of clinical interventions or procedures
   A22	A16/A17	Potential risks and burdens
   A23	A14	Potential for distress in interviews, questionnaires, or group discussions
   A24	A18	Potential benefits
   A25	A67	Arrangements for continued provision of intervention after research finished
   A26	A19	Potential risks for researchers

   
   
Research procedures, risks and benefits



IRAS question number	Reference in NRES application form or other source	Subject
A27-1	A20 (part)	Identification of potential participants
A27-2	None	Screening personal data
A27-3	None	Methods/resources
A27-4	None	Access to personal data outside the care team
A27-5	None	Consent to access identifiable data
A28	A21	Details of recruitment through posters or adverts
A29	A20 (part)	How and by whom potential participants will be approached
A30-1	A26	Informed consent
A30-2	A27	Recording consent
A30-3	NIGB form	Use of data without consent
A31	A28	Time to decide on participation
A32	A25	Participants involvement in other research
A33-1	A29	Participants with inadequate English language skills or special communication needs
A33-2	None	Welsh language
A34	A30	Providing information to participants during the research
A35	A30-1	Loss of capacity to consent during the study


Confidentiality



IRAS question number	Reference in NRES application form or other source	Subject
A36	A39	Checklist of data processing activities
A37	NIGB form	Physical security of data storage
A38	A40	Confidentiality of data
A39	NIGB form	Separation/encryption of identifiers
A40	A43	Access to identifiable data during the study
A41	A41	Analysis of data and location
A42	A42	Data custodian
A43	NIGB form	Retention of identifiable data at end of study
A44	A44	Period of data storage
A45	NIGB form	Long term arrangements for data storage


Incentives and payments



IRAS question number	Reference in NRES application form or other source	Subject
A46	A33/A34	Financial payments/incentives (participants)
A47	A61/A62	Financial payments/incentives (researchers)
A48	A64	Conflicts of interest


Notifying other health professionals



IRAS question number	Reference in NRES application form or other source	Subject
A49-1	A32a	Notifying GP or health professional
A49-2	A32b	Permission to notify


Publication and dissemination



IRAS question number	Reference in NRES application form or other source	Subject
A50	None	Trial registration
A51	A37	Dissemination of study results
A52	NIGB form	Ensuring the anonymity of published data
A53	A38	Informing participants of the study results




5. Science

   IRAS question number	Reference in NRES application form or other source	Subject
   A54	A45-1	Scientific critique
   A55	None	Assessment by Expert Advisory Group and Commission on Human Medicine
   A56	A45-2	Statistical critique
   A57	A48	Primary outcome measure
   A58	A49	Secondary outcome measures
   A59	A50	Sample size
   A60	A51	Sample size determination
   A61	A52	Randomisation
   A62	A53	Methods of analysis




6. Management of the research

   IRAS question number	Reference in NRES application form or other source	Subject
   A63	A66	Key collaborators
   A64-1	A59	Lead sponsor
   A64-2	A59	Sponsor's contact point
   A64-4	A59	Legal representative in EEA
   A65	A58	External funding
   A66	A60	Subcontractors
   A67	A55	Previous rejection by a REC
   A68	None	Lead R&D contact
   A69	A3	Duration of study
   A70	None	Definition of the end of the study
   A72	A56	Overview of host organisations
   A73-1	None	Identification of participants by other organisations
   A73-2	None	NHS participant identification centres (PICs)
   A73-3	None	Resources for PICs
   A74	A57	Monitoring and auditing the conduct of the research
   A75	A57a	DMC and stopping rules
   A76-1	A35-1	Insurance/indemnity - management of study
   A76-2	A35-2	Insurance/indemnity - design of study
   A76-3	A35-3	Insurance/indemnity - conduct of study
   A77	A36	No fault compensation
   A78	A10-3	Intellectual property
   A79	None	Level of commercial participation

PART B - Additional information for specific applications

IRAS question number	Reference in NRES application form or other source	Subject
B1	EudraCT form	Investigational medicinal products
B2	B2	Medical devices (populates MHRA Devices forms)
B3	B3	Exposure to ionising radiation (populates ARSAC forms)
B4	B4	Use of existing human tissue samples
B5	B5	Use of new human tissue samples
B6	B7	Adults unable to consent for themselves
B7	None	Children
B8	NIGB/HES Forms	Additional information for NIGB (populates NIGB form)
B9	NIGB security form	Information security measures (populates NIGB form)
B10	MoJ forms	Additional information for Ministry of Justice (populates MoJ form)

PART C - List of research sites

IRAS question number	Reference in NRES application form or other source	Subject
C1	B1	List of research sites NHS participant identification centres (for R&D offices only)

PART D - Declarations

IRAS question number	Reference in NRES application form or other source	Subject
D1	B7	Chief Investigator
D2	B7	Sponsor's representative
D3	A71	Academic supervisor
D4	NIGB Form	Information Guardian (NIGB only)