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When presented with a proposal to participate in a particular research study, we consider a variety of factors. As we are primarily a neurological practice, we limit our research interests to disorders that are within the realm of central and peripheral nervous disorders. We have traditionally met or exceeded enrollment goals because of our realistic approach to study selection. We scrutinize each study protocol with the following considerations:
If the research being proposed is acceptable to us, we initiate the regulatory process including filing of forms to the FDA, IRB, Sponsor and if necessary, CRO. Contract review and approval and regulatory submission of the packet is usually done within 3 business days as we have a dedicated regulatory department. We are usually among the first sites with IRB and regulatory approval. Study patients are recruited using the following means:
Pre-screening is performed by our study coordinators or Principal Investigator, either by chart review or telephone initially. Pre-screened subjects are brought in by appointment and presented with a copy of the informed consent document specific to the study for which they are being considered. They are given an unlimited period of time to review the IC document and then qualified staff will sit down with the prospective study subject and if necessary, the caregiver and answer any questions they might have about the study. As long as all questions are adequately addressed and the subject agrees to participate in the study, the documents are signed by all necessary parties and copies are provided to the study subject. Study procedures are initiated hence only after these events have been acceptably completed. We have been quite successful in maintaining high retention rates throughout our study protocols by striving to make our study subjects comfortable in many ways:
Study Follow up: We consider communication with the sponsor, CRO and IRB of paramount importance in the implementation and completion of any study protocol. This includes preparing CRF completion for monitor review and drug accountability; punctual completion of online (E-CRF) data forms; rapid turn-around in responding to data queries; Immediate reporting of serious adverse events to sponsor, CRO and IRB; answering any email, fax and/or telephone call punctually. We store CRF and other study related information as per our requirement at a long term temperature control facility that specializes in long term document storage in Los Angeles. We provide study monitors with adequate space, desks and equipment including telephone, fax, copier and high speed internet connection to complete their work comfortably while they are in the office. Our attitude is that we are all working together for a common purpose. |
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