ORC Data Transfer Intake Form (DTIF) for IRB Review
Please fill in as much information as possible and email completed Wordformto .
- Data will be transferred from ______(Discloser) to ______(Recipient); check here ☐if data will flow both ways, i.e., to and from each party(ies).
- If Duke is the Discloser, Duke’s source of data is ___standard of care or ___research study.If a research study, provide name of PI ______,study name ______, eIRB#Pro000______,research study’s source of funding______andSPS#______.
- Recipient will use data for ____ registry, ____business operations or ____ research study. If a research study, provide name ofPI______and studyname______;if Duke is Recipient and data will be used for a research study, also include eIRB#Pro000______, research study’s source of funding ______and, if any, SPS# ______.
- Discloser will provide data to Recipient via: _____Access credentials to file server; _____Duke Box (Duke IRB prefers the use of Duke Box when possible); _____REDCAP; _____other Internet file transfer system; _____Physical digital media, such as flash drive or hard drive; _____ Physical printed media, such as paper binder
- PleaseXall HIPAA identifiers listed below that will be disclosed:
☐Names
☐Geographic designation, other than country or state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes; will ZIP Codes, in whole or in part, be provided? _____ (Y/N)
☐All elements of dates (except year alone) directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older
☐Telephone numbers
☐Facsimile numbers
☐Electronic mail addresses
☐Social security numbers
☐Medical record numbers
☐Health plan beneficiary numbers
☐Account numbers
☐Certificate/license numbers
☐Vehicle identifiers and serial numbers, including license plate numbers
☐Device identifiers and serial numbers
☐Web universal resource locators (URLs)
☐Internet protocol (IP) address numbers
☐Biometric identifiers, including fingerprints and voiceprints (including audio recordings)
☐Full-face photographic images and any comparable images
☐Any other unique identifying number, characteristic or code; indicate whetherRecipient will have access to key to re-identify data using such other unique identifier(s)_____ (Y/N)
- Provide brief scope of work and description of data flow, including source of data, what data will be transferred by Discloser,how data will be disclosed to Recipient, and how Recipient will use the data.
- Does thetransfer include samples?______If so, are the samples de-identified?____ (Y/N)
- Do you intend to transfer technical data, including biomarker, sequence, protein, lipid, chemical or expression level data? ______
- Does the applicableDiscloser ICF allow disclosure of the data to Recipient? ____ (Y/N) Does the applicable Discloser ICF allow use of the data by Recipient? ____ (Y/N) Comments, if any: ______
- Will payment be exchanged in connection with data transfer or use? ____ If so, describe:______
- Contract under which Discloser will disclose data to Recipient, i.e., RSSA, OSA, sub-agreement, DTA, DUA, don’t know, other:______
- Will mobile Apps be used to collect, store or transfer the data?______
- Will Recipient have remote access to any Duke systems?_____ If so, which ones? ______
- Is there intent for Recipient to further disclose the data?_____ If so, describe: ______
- Does Discloser want publication rights regarding disclosure or use of data?____ If so, describe: ______
- Provide name, title and email address for each person to whom OCRC will send draft agreement:
Submitted by: ______Date: ______