OHSU

Study Coordination:

OCTRI can provide Study Coordinators who are trained in all aspects of clinical train conduct for adult and pediatric trails. We can step in during times of department personnel turn over, cover during leave of absences or simply provide full service for your study from start up close out. See below for examples of tasks that can be completed by our Study Coordinator team. If you have a specific need that you do not see listed below, please contact us to discuss the potential for training our staff to assist you in whatever way your study requires.


Survey Administration & Data Entry

OCTRI Study Coordinators are trained to administer a wide variety of written, oral and computer based surveys, questionnaires and tests. Coordinators are also prepared to learn how to administer and score new intsruments based on specific protocols.

In addition to survey administration, study coordinators are trained in efficient in accurate data entry. Staff are committed to meeting investigator needs and will meet with the study team to confirm data input and output.

OCTRI Study Coordinators are highly experienced in data entry in Excel and REDCap. REDCap is a secure web-based database designed for data tracking for research studies and has a survey fuction similar to Survey Monkey.

Learn more about REDCap


ONGOING REGULATORY DOCUMENTATION

Conducting research involving human subjects requires ongoing review and approval by the Institutional Review Board (IRB), Federal, State and institutional policies govern this process.

OCTRI Study Coordinators are experienced in submitting ongoing documentation to the IRB. This documentation includes: protocol modifications, adverse events (AEs) and the Continuing Review Questionnaire (CRQ).

 

RECRUITING, SCHEDULING & CONSENTING STUDY PARTICIPANTS

OCTRI study coordinators are prepared to assist with study activities from recruitment to consenting and through data and specimen collection. Study coordinators are experienced in standard and novel recruitment methods, and they have a track record of successfully recruiting participants for studies, including child health protocols, with very stringent exclusion criteria. Coordinators can also manage the entire participant scheduling and consenting process.

There are several tools available to determine study feasibility and to help you recruit participants for your research. 

 

PREPARATION OF STUDY DOCUMENTATION

OCTRI study coordinators prepare the following documentation as part of study set-up:

  • Regulatory binder
  • Source documentation
  • Participant visit packets
  • Additional documentation based on the protocol's unique needs
Study coordinators can also train non-OCTRI study staff, conduct in-services for partnering departments (most often the Research Pharmacy and labs), and coordinate site visits for industry-sponsored studies.

 

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DRUG COMPLIANCE, COORDINATION & RECONCILIATION

CTRC Drugs ServicesOCTRI study coordinators can work with the OHSU Research Pharmacy to maintain the necessary stock of medications required for the protocol. 

Industry-sponsored studies often require regular check-ins with the Research Pharmacy and sponsor or drug supplier. Study coordinators can manage this important aspect of clinical trials.

 

Related Institutional Links