Abbreviations
IRB: Institutional Review Board
IT: Information Technology
OHRP: Office for Human Research Protection (Federal Agency)
OIT: Office of Information Technology
PI: Prinicipal Investigator
SOPs: Standard Operational Procedures
Definitions
Click on to see definition.
Anonymous Data

Coded Data

Confidential Data

Data Monitoring and Safety Plan
It is the policy of the NIH that each Institute and Center (IC) should have a
system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the
data for all NIH-supported or conducted clinical trials.
De-Identified Data

Individually Identifiable 2

Protected Health Information (PHI) 3

- Transmitted by electronic media;
- Maintained in electronic media; or
- Transmitted or maintained in any other form or medium by a Covered Component.
PHI excludes individually identifiable health information in:
- Educational records covered by the Family Educational Rights and Privacy Act (FERPA);
- Records described in 20 U.S.C. §1232g(a)(4)(B)(iv);
- Employment records held by a covered entity in its role as employer; and
- Regarding a person who has been deceased for more than 50 years.
Personal Identification Information (PII) 4

PII includes:
- Name, postal or electronic mailing address, telephone number, Social Security number, date of birth, mother's maiden name, official state-issued or US-issued driver's license or identification number, alien registration number, government passport number, employer or taxpayer identification number, Medicaid or food stamp account number, bank account number, credit or debit card number, or personal identification number or code assigned to the holder of a debit card by the issuer to permit authorized electronic use of such card;
- Unique biometric data, such as fingerprint, voice print, retina or iris image, or other unique physical representation;
- Unique electronic identification number, address, or routing code;
- Medical records;
- Telecommunication identifying information or access device;
- Other number or information that can be used to access a person's financial resources.
Private information

Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for the obtained information to constitute research involving human subjects, 45 CFR 46.102(f). 2
Sensitive Research Data
