Clinical trial query

Quality Assurance in Clinical Research trials

The Quality Assurance Plan (QA Plan) is designed to ensure that clinical studies conducted at Children's Hospital Los Angeles adhere to their respective research protocols, applicable federal and state regulations, the ICH-GCP guidelines and all relevant Children's Hospital Los Angeles policies and procedures. The QA Plan consists of two major components – the Education Plan the Audit Plan.

EDUCATION PLAN

The education plan will consist of:

  • Study Initiation Visits,
  • Training – both in service and scheduled classes,
  • CCI Quality Assurance web site section, and
  • Consultation services.

Study Initiation Visits

For all investigator-initiated, greater than minimal risk studies, the QA and Education Specialist (Specialist) will visit with the research team prior to the initiation of study activities. Industry sponsored and multicenter funded studies will be included as time permits. At the Study Initiation Visit, the Specialist will acquaint the research team with the basic principles of the ICH-GCP guidelines. The main focus of the visit will be on the record keeping requirements for the clinical trial.

The Specialist will take a practical and directional approach at the Site Initiation Visit by presenting the research team with two pre-tabbed binders in which to organize the most important clinical trial documentation. The purpose of these binders is to standardize record keeping for clinical studies and to increase compliance with the ICH- GCP guidelines.

One binder, the study binder, will store the documents pertinent to the research study (including the protocol, investigator’s brochure, CCI approval letter, informed consent document, sponsor contracts, SAE reporting plan, the delegation of authority form, the shipping related documents, normal values for lab ranges, and the pre-monitoring and site initiation visit reports from the external or internal monitors or investigator meeting attendance records). The second binder will store the essential logs which will have to be updated during the course of the clinical study (including logs for patient screening, patient enrollment, patient eligibility assessment, source documentation, SAEs, site monitoring reports, IRB and sponsor related correspondence, and drug accountability forms).

Training

In service training and classes will be administered to research staff on an as-needed and scheduled basis and will consist of presentations on ICH- GCP guidelines and pertinent FDA regulations and Children's Hospital Los Angeles policies and procedures.

Study Initiation Visit

In an attempt to improve the practice of clinical research at Children's Hospital Los Angeles, the CCI is pleased to introduce a Quality Assurance and Education program. Our goal is to conduct study initiation visits with the research team prior to the start of all greater than minimal risk studies. At the...

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Popular Q&A

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What IS THE SALARY RANGE FOR A QUALITY ASSURANCE ASSOCIATE WORKING FOR A CLINICAL RESEARCH ORGANIZAATION

Depends on your experience...entry level would be about $15-18/hr here in CA

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