East Norfolk & Waveney Research Governance Committee

Roles and Responsibilities of Researcher

The 1Chief Investigator has

Primary responsibility for the design management cond!ct analyses and

reporting of the st!dy to the standards set o!t in the Research Governance "rame#ork2 or manages those #ith delegated a!thority for these aspects involved in the st!dy%

Responsibility for co$ordinating the investigators #ho take the lead at each site Responsibility for ens!ring that research is cond!cted to an agreed protocol &or
proposal'( acco!ntability for this is to the chief investigator)s employer and thro!gh them to the sponsor of the research%

Chief and Principal Investigators m!st ens!re that research is carried o!t in accordance #ith the Research Governance "rame#ork and IC* GCP g!idelines% This incl!des+ Study approvals

The st!dy complies #ith legal and ethical re,!irements% -pplication is made to a N*. research ethics committee the research does not
commence before a favo!rable opinion is received and the research team acts on any conditions attached to the ethical approval%

That the Chief E/ec!tive &or those #ith delegated a!thority to ens!re the

implementation of the Research Governance "rame#ork' is informed that the st!dy is planned and their permission is obtained before the research starts% This is done thro!gh completion of the registration form and s!bmission to the Research Governance Committee%

Changes to the protocol or proposal are reported to the Research Governance

Committee and the appropriate Research Ethics Committee &REC' for revie#% -pproval is obtained before any changes other than !rgent safety meas!res are implemented%

Conduct of the study

The research is cond!cted to high ethical standards follo#ing independent

e/ternal revie# #herever possible

The st!dy is cond!cted according to a #ritten protocol% The investigator #ill be

f!lly conversant #ith the details of the st!dy protocol and the dr!gs devices and proced!res !sed in the st!dy and are satisfied that the ob0ectives of the st!dy are appropriate and the methods !sed are valid%

1 C2REC definition+ Chief Investigator is the person #ith overall responsibility for the research and all applications m!st be s!bmitted by the Chief Investigator

2
3 C2REC definition+ Principal Investigator is the person responsible for the research at a site% There is one PI per site% 1 4epartment of *ealth &5661' Research Governance "rame#ork for *ealth and .ocial Care% 4epartment of *ealth+ 7ondon% .econd edition in draft 5668
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 Each member of the research team incl!ding those on collaborating sites is

,!alified by ed!cation training and e/perience%

4elegation of d!ties and responsibilities is formally recorded and reported% Each investigator in a clinical trial involving medicine is a#are of their d!ties in
respect of the E9 4irective on Clinical Trials2 and is appropriately trained in the principles of Good Clinical Practice 3

.t!dent and ne# researchers have ade,!ate s!pervision s!pport and training% Controlled trials are registered and for clinical trials involving medicines the
research follo#s any conditions imposed by the licensing a!thority &:edicines and *ealthcare Reg!latory -!thority' and E9 Clinical 4irective%

-rrangements are made for the management of financial and other reso!rces

provided for the st!dy incl!ding for the management of any intellect!al property arising%

-ll data and doc!mentation associated #ith the st!dy are available at the
re,!est of the internal or e/ternal inspectors or a!ditors%

Participants involvement

Participant dignity rights safety and #ell$being are given priority at all times% When the st!dy involves participants !nder the care of a doctor n!rse or social
#orker for the condition to #hich the st!dy relates those care professionals are informed that their patients or !sers are being invited to participate and agree to retain overall responsibility for their care%

When the research involves a social care service !ser or carer or child looked

after or receiving services !nder the a!spices of the local a!thority the agency director or her dep!ty agrees to the person ∧or their carer' being invited to participate and is f!lly a#are of the arrangements for dealing #ith any disclos!res or other relevant information%

9nless participants or the relevant research ethics committee specify other#ise

participants) care professionals are given information specifically relevant to their care that arises in the research%

Data collection, analysis and publication

Proced!res are in place to ens!re collection of high ,!ality acc!rate data and

the integrity and confidentiality of data d!ring processing and storage% -rrangements are made for the appropriate archiving of data #hen the research has finished%

Reports on the progress and o!tcomes of the #ork re,!ired by sponsors

f!nders Research Governance Committee and 7REC are prod!ced to time and to an acceptable standard%

5 The E9 4irective on GCP in Clinical Trials &5661;56;EC' 88 IC* G!ideline for Good Clinical Practice &E<' &:ay 1==<'
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 "indings from the #ork once critically revie#ed thro!gh accepted channels The investigator plays a key role in detecting and preventing scientific
miscond!ct by adopting the role of g!arantor on p!blished o!tp!ts

sho!ld be disseminated promptly and fed back as appropriate to participants

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