CTSU Privacy Act Memo

DATE:

August 5, 2020

TO:

Michael Montello, Pharm. D.
Cancer Therapy Evaluation Program (CTEP)
Division of Cancer Treatment and Diagnosis (DCTD)
National Cancer Institute (NCI)

FROM:

NIH Privacy Act Officer

SUBJECT:

Applicability of the Privacy Act: “CTEP Branch and Support Contracts Forms
and Surveys (NCI)”

I have reviewed the NCI submission to the Office of Management and Budget under the Paperwork
Reduction Act. NCI CTEP and the Division of Cancer Prevention (DCP) fund an extensive national
program of cancer research, sponsoring clinical trials in cancer prevention, symptom management
and treatment for qualified clinical investigators. As part of this effort, CTEP implements programs
to register clinical site investigators and clinical site staff, and to oversee the conduct of research at
the clinical sites. CTEP and DCP also oversee two support programs, the NCI Central Institutional
Review Board (CIRB) and the Cancer Trial Support Unit (CTSU). The combined systems and
processes for initiating and managing clinical trials is termed the Clinical Oncology Research
Enterprise (CORE) and represents an integrated set of information systems and processes which
support investigator registration, trial oversight, patient enrollment, and clinical data collection. The
information collected is required to ensure compliance with applicable federal regulations governing
the conduct of human subjects research, and when CTEP acts as the Investigational New Drug (IND)
holder. Survey collections assesses satisfaction and provide feedback to guide improvements with
processes and technology.
I have determined that the Privacy Act will apply to this data collection which involves the
collection of personally identifiable information such as name, date of birth, social security number,
mailing address, telephone number, medical record number, email address, gender, ethnicity,
financial information, educational level, etc.
This data collection is covered by NIH Privacy Act System of Records 09-25-0200, “Clinical, Basic
and Population-based Research Studies of the National Institutes of Health (NIH), HHS/NIH/OD.”
If you have any questions, please contact my office at (301) 402-6201.

Celeste Dade-Vinson
cc: Diane Kreinbrink