Effective Site Management in Clinical Research - Points to Consider

Effective Site Management in Clinical Research - Points to Consider


Clinical trials are essential to deliver new therapies and advance medical knowledge and patient care. A key aspect of a successful clinical trial is the efficient management of clinical sites.

Site management in clinical research

Efficient site management is essential to ensure that the clinical study runs smoothly and results in the best outcome. Selecting sites as per the study protocol and the applicable regulatory requirements can positively impact the quality of data collected and ensure that the study is conducted as per the agreed timelines and within the budgets.

Site management activities

Site management in clinical research involves effective site monitoring and constant communication between the various stakeholders throughout all phases of the clinical study – study start-up, study conduct, and study closure. A CRA or Site Manager is responsible for ensuring efficient site management in various clinical study projects.

Site management activities followed before study start-up:

  • Management and review of clinical trial feasibility
  • Site qualifications - Site selection and pre-study visits
  • Selection of study investigator
  • Contract and budget execution
  • Vendors approval and setup

Site management activities at the time of study start-up:

  • Oversee start-up
  • Site activation, site initiation visits
  • Set recruitment expectations
  • Ensuring training

Site management activities during the enrolment period:

  • Facilitation and review of enrolment
  • Ensuring regulatory compliance and adherence to the protocol
  • Management of adverse event reporting
  • Study document review and query resolution
  • Study monitoring - Remote and on-site
  • Data collection

Site management activities during study close-out:

  • Ensuring protocol adherence
  • Addressing data queries
  • Ensuring final source data verification of study documents
  • Managing the collection of final safety data
  • Review and accountability of all study drug
  • Assessment and collection of all relevant regulatory documents
  • Ensure audit readiness
  • Ensure record retention requirements

Why is site management important?

Efficient clinical site management is essential for the smooth execution of clinical trials to ensure the optimal trial outcome. Proper site management enables sites to effectively recruit and retain subjects while adhering to the study protocol and relevant regulatory guidelines.

The key to strong collaboration with the sites is ensuring proper site management throughout all phases of a trial. Strong collaboration ensures increased efficiency, consistent communication, adherence to regulations and improved data quality.

CliniExperts - Clinical site management services

CliniExperts has an exceptional track record in clinical site management that ensures scientific excellence and data integrity across all sites. We engage highly competent clinical research associates to perform all aspects of site management throughout the study. Our team of experts exercise ultimate efficiency in managing

investigator sites and focus on ensuring adherence to data quality, subject safety, and early issue resolution throughout the trial. Our experts oversee data collection, review source documentation and case report forms, ensure regulatory compliance and resolve data queries. We also conduct interim analyses as requested by the client.

As part of our site management services, we also support the training of site staff to meet industry compliance standards and ensure that the site and the staff are adequately prepared for audits and inspections. Critical to a successful clinical trial is ensuring proper site management during all phases of a trial. Efficient site management ensures scientific excellence and data integrity across all sites.

References

  1. Farrell B, Kenyon S, Shakur H. Managing clinical trials. Trials. 2010;11:78.
  2. Study Management. The University of Texas Health Science Center. Available at:https://www.uth.edu/ctrc/trial-conduct/study-management.htm. Accessed: 21 May 2021.


Frequently Asked Questions

What is an “orphan drug” as per the New Drugs and Clinical Trial Rules, 2019?

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met: Similarity with respect to quality has been proven to reference biologic Similarity with respect to preclinical assessment has been proven to reference biologic Clinical safety and efficacy is proven in one indication Mechanism of action is same for other clinical indications Involved receptor(s) are same for other clinical indications New indication not mentioned by innovator will be covered by a separate application.

The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

Yes. Clinical trial at each site shall be initiated after the approval of the clinical trial protocol and other related documents by the Ethics Committee for that site, registered with the CLA.

An audio-video recording of the informed consent process in case of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

The three tier mechanism comprises the following authorities: 1. Institutional Biosafety Committee (IBSC) at the Institute/ company – To ensure biosafety on-site 2. Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology - Managed genetically engineered cell banks 3. Genetic Engineering Appraisal Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)- for genetically modified organisms/ living modified organisms

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial of a biological product can submit application for clinical trial.

After obtaining permission in CT-11 or CT-14 or CT-15 as the case may be, the person, who intends to manufacture the biological product for CT, shall make an application for grant of license to manufacture the biological product by the respective State Licensing Authority (SLA) in accordance with the provisions of the Act and the Drugs and Cosmetics Rules, 1945.

No. For biological product and substances discovered or developed in countries other than India, Phase I data should be submitted along with the application. After submission of Phase I data generated outside India to the Central Licensing Authority, permission may be granted to repeat Phase I trials or to conduct Phase II trials and subsequently Phase III trial concurrently with other global trials for that biological product.

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