The Clinical Trials Office serves as a central point of contact for sponsors investigators who are affiliated with our hospital, attending physicians interested in conducting a clinical trial and physicians looking to refer a patient for a research project.
We facilitate and coordinate all clinical research activities to expedite study initiation and to ensure strict compliance with the highest standards of research conduct. We offer:
- Centralized clinical trial management
- Extensive experience in pharmaceutical and medical device trials
- Diverse inpatient and outpatient populations
- Expert oversight of clinical trial conduct
- Professional, experienced clinical research coordinators
- Physician investigators in most therapeutic areas or specialties
- Clinical Trial Management System (CTMS)
- Subject recruitment and screening
- Strict compliance with FDA and good clinical practice standards
- Complete financial and administrative management
- Prompt review and execution of contracts
- Dedicated, experienced research pharmacists
- Formal standard operating procedures (SOP) and research policies accessible via a web-based application
Institutional Review Boards (IRB)
Reading Hospital provides commitment, leadership, infrastructure, continuing education and compliance oversight necessary to protect human subjects. It must also provide written assurance to the appropriate federal agencies that the organization conducts research in accord with accepted ethical standards and specific regulatory requirements (the “Common Rule”).
The IRB requires that all investigators, study coordinators and research staff complete an IRB-approved education component in human subject protection as well as periodic continuing education programs.
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 a.m. to 8 a.m. Members include clinicians from major departments. The Director of Nursing Research, a member of the Nursing Research Council, and the VP of Academic Affairs along with the Director, Clinical Trials Office are also represented. The Chair is selected by the committee at large. The Council mission:
- Provides 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)
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