Research Advisory Council
The Research Advisory Council (RAC) is composed of a multi-disciplinary group of clinicians who possess skills in the elements of scientific inquiry. RAC meets the first Tuesday of each month from 7 to 8 a.m. Members include clinicians from major departments. The Director of Nursing Research, a member of the Nursing Research Council, the VP of Academic Affairs, and the Director, Clinical Trials Office, are also represented. The Chair is selected by the committee at large. The Council mission:
- Provide informal guidance to members of the Reading Hospital community who wish to participate in investigator-initiated research.
- To formally review all investigator-initiated research proposals prior to Institutional Review Board (IRB) review, and to provide the IRB with an opinion regarding the scientific merit of the proposal.
- In addition, the Council will review competitive grant requests and appropriate grant funds from a yearly pool, donated by the hospital and Medical Staff.
Investigational Drug Service (IDS) - Pharmacy
The Investigational Drug Service (IDS) supports all clinical drug-related research conducted at Reading Hospital. The IDS provides the support needed to assure safe and efficient conduct of clinical drug trials, including compliance with federal, state, and The Joint Commission on requirements regarding investigational drugs.
All investigational drugs are stored within a specially locked area to limit access by non-authorized personnel. The IDS maintains separate IDS refrigerators and freezers. Facilities are available for all extemporaneous compounding of oral, topical, and parenteral formulations. The IDS is able to dispense investigational medications to both inpatients and outpatients. IDS policies and operation procedures are maintained. The IDS is open for inspection by all investigators and sponsors.
Services Provided by IDS
- Development of educational materials and training for patients and staff
- Drug information services and literature search related to investigational studies
- Assistance with protocol development
- Blinding methodologies
- Preparation of oral, rectal, topical, and parenteral dosage forms and matching placebo
- Limited access and security of study drugs
- Appropriate storage according to FDA guidelines
- Maintenance and control of investigational drug inventories
- Performance of randomization services, such as IVRS for multicenter investigations
- Daily access to randomize, enroll, and dispense study agents to consented subjects
- Maintenance of Drug Accountability Record Forms (DARF) and all study-related files
- Collection of all patient drug returns and reconciliation
- Inventory control and return of all used and unused study drug to the sponsors
- Participation in final close-out of study protocols with the sponsors by providing copies of all drug disposition and inventory control records
- Drug destruction policies in place to destroy expired or used drug on site
- Participation in FDA, NCI, NIH, and pharmaceutical sponsor audits
For more information contact:
Information Manager, Pharmacy
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Additional Research Resources
In addition to the research resources listed above, Academic Affairs and Clinical Trials Office also include a biostatistician, SPSS software, and Medical Library staff to help support the needs of the investigators in their research being conducted. Also included are how-to write biological sketches from the NIH and NSF for grant applications.