Assessing Protocol Feasibility Purpose
To describe the procedures for assessing the feasibility of conducting a study at site (referred as Site) in compliance with standard protocol.
Site is committed to maintaining the highest scientific c, clinical and ethical standards while conducting research at the Site. Further, the Site is committed to complying with all applicable regulations and guidelines in the is regard. In view of the same, before agreeing to participate in a clinical research study, the Principal Investigator (Pl) and Institution must agree to the scientific, clinical, and ethical merits of the study; the financial impact on the hospital; compliance with a regulation; and the operational feasibility of conducting the study at Site. This standard operating procedure (SOP) describes the steps for assessing the feasibility of conducting a research study at the Site.
This standard operating g procedure (SOP) describes the steps for fulfilling the regulatory, medical, and ethical requirements for assessing the appropriateness and feasibility of implementing a protocol within the site research network.
Scope
This SOP applies to the activities involved in assessing protocol feasibility for all research studies conducted at Site involving human subjects.
Procedure
Protocol Assessment
When a Sponsor/CRO contacts the study Site about a potential study, the Principal Investigator (PI) will assess whether or not it would be assessable to conduct the protocol with the existing staff and facilities.
Clinical/Scientific /Ethical Feasibility
• Clinical importance to Site patients/subjects.
• Scientific c merit.
" Benefits and risks associated with the protocol.
"Consistency with the priorities of the hospital and the clinical department.
Operational Feasibility
• Availability of personnel and other resources required to conduct the study.
• Availability of patients meeting the inclusion/ exclusion criteria of the study
• The level of interest expected from the physicians needed to recruit patients into the study.
• The operational complexity of the protocol.
• Whether there are any conflicting studies in progress.
Regulatory Feasibility
• The Pl reviews the protocol to determine whether there is anything required that may be problematic when submitting the project to the Institutional Ethics Committee (referred to as IEC). Apart from the review the Clinical Trial Coordinator (refereed as CTC) can consult with IEC representatives.
• The Pl must check the following points before submitting the protocol to the IEC for approval, as IEC determines:
o Research studies have the resources necessary to protect participants.
o Adequate time for the researchers to conduct and complete the research.
o Adequate number of qualified staff
o Adequate facilities
o Assess a population that will allow recruitment of other necessary numbers of participants.
o Availability or medical or psychosocial resources that participants might need as a consequence of the research.
Financial/ Legal Feasibility
" A detailed review of the costs, including staff time needed to complete protocol activities and patient care visits are determined by the Pl.
" The Pl and CTC prepare the budget worksheet.
• The budget worksheet is compared with the sponsor's budget.
• The Pl and CTC will negotiate with the sponsor to establish a feasible budget. Once an agreement is made. the budget will be signed by the Pl and sent to the sponsor.
o II" an agreement cannot be reached with the study sponsor to cover all costs of the study, the Pl' and CTC will work together to determine whether the study will be conducted at the site.
• The Legal expert will facilitate legalities.
Decision
The Pl will notify the sponsor (in case of sponsored study) of the Site's decision. In the event that the protocol does not meet the above-mentioned criteria, the convener may, at his/her discretion, provide the rationale for the decision to the PI and Pl will inform the same to the sponsor, allowing the Sponsor the opportunity to make changes in the suggested part of the protocol and have it reassessed.
Applicable Staff
This SOP applies to all the personnel or the clinical research team and the Pl and others who may be responsible e for making decisions regarding the conduct of the research studies at the site
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