Page 6 - Research Compliance Welcome Package (1.4.19)

Building Blocks for Compliant Research (Top Ten Reminders to Assist in the Successful Conduct of Clinical Research)
Communication
Regular meetings with the PI and study team help monitor study progress or problems and assist with timely documentation. Communication between the study team and IRB, Research
Operations, Compliance, and others is vital, so don’t be afraid to let your voice be heard!
Regulatory and Policy Awareness
Familiarize yourself with regulations and institutional policy applicable to the type of research in which you are involved and make sure to follow them. If you’re not sure if something applies, then ask.
Training and Education
Maintain records of all relevant and required training and education for key study personnel. Include formal documentation of any education of staff conducted as part of a corrective or preventive action when issues are identified.
Privacy in Research
Subject confidentiality should always be maintained in research; however, there are additional specific requirements under HIPAA for use and disclosure of “Protected health information” or PHI in research. Be certain to only use/disclose PHI, if appropriate, according to the applicable
privacy authorization, data use agreement, or other mechanism allowable per HIPAA.
Precise Eligibility Documentation
Eligibility criteria are often critical for preventing subject harm and an important part of the
research record. Make sure eligibility documentation is clear and precise. Don’t forget self reported data or information not routinely noted in the health record!
Robust Consent Process Documentation Remember to document the consent discussion in the research or medical record, as
appropriate. This goes beyond the signed consent form and helps document regulatory requirements have been met (a copy was given to the subject, consent was obtained prior to any research procedures being conducted, special circumstances, etc.).
Test Article Accountability
Make sure test article accountability is correct and up
use and return/destruction of test article. Small mistakes here can have a big impact, so
be extra diligent and double
Protocol Adherence
A study is to be conducted according to the IRB
on how the study is to be carried out are often made via responses to questions in submission forms to the IRB. Be proactive in developing eligibility and visit checklists to prevent deviations.
Quality Source Documentation
If it’s not documented, it didn’t happen. Source documents, such as those maintained in medical or research records, must meet standards that allow for reconstruction and validation of trial data. Check out our ALCOA handout for more detail!
Record Retention
Different studies have to be stored for different lengths of time depending on which regulations
are applicable (e.g., FDA
requirements). Know how long to store your records and where they are kept in case they’re needed in the future such as for an audit!
BSWH Research Compliance | 2401 S. 31st St. | MS-AR-M300 | Temple, TX 76508
254-215-9025 (x21-9025) Office | 254-215-9061 Fax | Research Compliance Office | ResearchCompliance@BSWHealth.org
-
-
to
-
date for receipt, assignment,
-
check!
-
approved protocol. In addition, commitments
-
regulated studies are typically longer and driven by FDA and sponsor
09/10/18