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RESEARCH & DEVELOPMENT OFFICE

Vision:

NEMROCK Research and Development Office (NRD) is aiming to make NEMROCK one of the leading research cancer centers in the Middle East having the capability for translational research adjusted to our population of specific genetics. 

Objectives:

·        To foster a culture of research and development within NEMROCK.

·        To continually review NEMROCK guidelines in line with evidence based practice and Peer Review standards.

·        To review and evaluate service development proposals and recommend implementation or further review to ensure that service continuity is maintained in a cost effective and efficient manner.

·        To review and evaluate research trial proposals as presented to NRD, and recommend participation or further review to ensure that business continuity is maintained in a cost effective and efficient manner.

·        To monitor progress of agreed developments and research trials to ensure that they reach the project conclusion in a timely manner

·        To make recommendations to department board when there are strategic and operational blockages to progress for final decision making.

·        Ensure effective communications through timely and open distribution of minutes

Structure:

NRD staffing includes:

§  Research office lead

§  Research coordinators:

Ø Assistant lecturers should dedicate one extraday for the unit

Ø Staff doctors could be either full time or part-time

§  Research nurses

§  Clinical pharmacist

§  Data managers (could be coordinator or nurse)

§  Accountant

§  Administration staff

            Service level agreement with:

§  Lab staff

§  Radiology staff

 

Type of research:

Different types of research include:

·        Pharma-sponsored studies

·        Investigator-initiated studies (including MSc or MD thesis running in the department)

·        Retrospective charts reviews

·        Annual reports

 

Policy of Responsibilities:

Ø Principal Investigator:

·        To discuss the clinical trial and agree on proceeding with it at the appropriate tumor working party/unit

·        To complete a proposal form and submit it to research scientific committee

 

Ø NRD Team:

·        To ensure that the PI of the clinical trial submits a form to research scientific committee

·        To ensure that all patients in research trials are recruited and managed according to the department policy

·        To inform the Radiotherapy committee Lead of any amendments to clinical trial protocols that involve Radiotherapy

 

Ø Scientific research committee:

·        To review and approve all clinical trials and developments

·        To assess the impact of a trial on department service including Radiotherapy Service

·        To inform the PI of a trial of any decision made or changes required

·        To facilitate the implementation of a clinical trial into radiotherapy clinical practice

 

Ø Radiotherapy committee Lead:

·        To ensure that the Radiotherapy Service takes any actions necessary to maintain compliance with the trial protocol

 

Ø All Staff:

·        To be aware of this policy and abide by it at all times

 

Policies and Procedures:

1.0 Clinical Trials

1.1 All patients in research trials will be managed in accordance with NEMROCK policy.

1.2 Approval from the scientific committee is required for all research undertaken in NEMROCK. This includes all research using its staff, patients, their data or tissues and/or resources. This approval must be in place prior to the research staring within the center.

1.3 The NRD is responsible for ensuring that all research within NEMROK complies with GCP and relevant legislation.

1.4 The principal investigator (PI) is responsible for obtaining approval for the study from the IRB/EC.

2.0 NEMROCK Research and Development Office (NRD)

2.1 The NRD group meets on a monthly basis to review, manage, and plan research and development activity within NEMROCK.

2.2 When a clinical trial proposal is received, each member of the group reviews the trial protocol, and the impact analysis, and assesses the effect on their particular area. The proposal will be approved, approved with conditions, or deferred until further information submitted. The NRD lead will notify the scientific committee of the decision.

2.3 A NRD report of trials submitted and reviewed by the group is presented at the department board meeting on a monthly basis.

2.4 The Research coordinator is responsible for ensuring that all relevant approvals and documentation, including approval from the relevant Research Ethics Committee, are in place before patients are recruited into the trial.

 

3.0 The Approval Process

3.1 Once the tumor specific research group has reviewed a trial protocol and agreed to participate in the study, the PI completes the form and submits to scientific committee. Particular attention should be paid to the impact analysis section of the form where the effect of the trial on different services provided is assessed.

3.2 When a trial proposal is received by scientific committee, it is sent to NRD office for review.

3.3 PI attends the monthly meeting of scientific committee in presence of NRD member to discuss any queries before final approval.

3.4 Following scientific committee approval, the form will be signed by the PI, committee chairman, and the NRD lead.

 

Financial arrangement:

NRD is aiming to be self-supported within 5 years. And to achieve this, a separate account within NEMROCK account is needed. A dedicated accountant will be responsible on budget (income and costs).

This should cover staff salaries, equipments’ maintenance and consumables as well as funding for future developments including research labs and biobanking.

For pharma sponsored studies, financial agreement should be signed with Head of department, Director of NEMROCK and PI.

 

Governance:

NRD lead should report every 3 months to scientific research committee

Performance assessment of unit staff as well as overall assessment is done through monitoring as well as monthly report of different metrics including:

·        Number of trials running

·        Number of patients enrolled

·        Number of CRF queries

·        Outcome of CRA monitoring

Accreditation

NRD aims to be accredited within the next 5 years and specific steps should be taken to achieve that goal.



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