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Roles and Responsibilities
Principal Investigator
Roles
Every study must have designated a Principal Investigator (PI) who takes
overall responsibility for the clinical component of the study, or the
interface and interaction with patients, records, or staff. There can
only be one PI in the eyes of the RM&G office, even for research across
more than one site.
Responsibilities
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the design, conduct and reporting of
the study and appropriate liaison with other
researchers. |
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ensuring that the research question is the most appropriate
given the context and the most appropriate given
the context and the proposed project is feasible, useful, safe,
legal, ethical and financially appropriate. |
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ensuring that the project has the approval of the
local PCT, the Ethics Committee and the Sponsor. |
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providing quarterly progress reports
to the RM&G office via e-mail, including monitoring of progress
with the agreed project timeline, and the prompt production of any
other agreed reports. |
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ensuring that the dignity, rights and well-being
of participants are respected and informed consent is gained. |
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ensuring that care professionals
are informed when their patients / clients are invited to participate,
agreeing that they retain overall responsibility for their care and
ensuring that feedback about the care of participants is passed to
usual care practitioner, unless there is specific agreement otherwise. |
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being accountable for the conduct of the research
problem-solving and ensuring that those working on projects have necessary
expertise or supervision. |
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ensuring that the approved protocol is followed.
Ensuring that any significant changes to the protocol are appropriately
negotiated and submitted to the ethics committee and the research
sponsor for approval. |
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implementing procedures to ensure collection of high
quality, accurate data and the integrity and confidentiality of data
during processing and storage. |
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ensuring findings are open to critical review and
significant findings are published within a reasonable time. |
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ensuring that all data and documentation are available
for audit. Ensuring appropriate archiving of data at end of study. |
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ensuring good financial and resource management of
intellectual property. |
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ensuring that controlled trials have been registered. |
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