Form 91 CTEP FDA Form 1572 for Annual Submission

Attachment E01 – NCI/DCTD/CTEP Modified FDA Form 1572

OMB #xxxx-xxxx
Expiration Date: xx/xx/xxxx

Public reporting burden for this collection of information is estimated to be 15 minutes per response, including the
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a currently valid OMB control number. Send
comments regarding this burden estimate or any other aspect of this collection of information, including suggestions
for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD
20892-7974, ATTN: PRA (OMB #xxxx-xxxx). Do not return the completed form to this address.

Screenshots

Figure 1: Form FDA 1572 - Electronic Capture of Practice Sites – Before Populating Sites

Figure 2: Form FDA 1572 - Electronic Capture of Practice Sites - After Populating Sites

Figure 3: Form FDA 1572 - Electronic Capture of Labs - Before Adding New Record

Figure 4: Form FDA 1572 - Electronic Capture of Labs - After Adding New Record

Figure 5: Form FDA 1572 - Electronic Capture of IRBs - Before Populating IRBs

Figure 6: Form FDA 1572 - Electronic Capture of IRBs - After Populating IRBs

Breakdown of Elements
There are three different sections of Form FDA 1572 that are electronically captured,
with the following information displayed for each section:
1. Practice Sites
a. Add New Record: Allows the investigator to manually search for and add a
practice site to their Form FDA 1572.
b. Populate Sites: Allows the investigator to automatically add sites to their
Form FDA 1572 based on the sites at which they are rostered and the
sites at which they are the Site-Protocol PI.
c. Delete: Allows the investigator to delete a practice site from their Form
FDA 1572.
d. CTEP ID: Displays the CTEP ID of the practice site.
e. Site Name: Displays the Name of the practice site
f. Site Address: Displays the practice site’s Address.
2. Labs
a. Add New Record: Allows the investigator to manually search for and add a
lab to their Form FDA 1572.
b. Actions: Allows the investigator to delete a lab from their Form FDA 1572.
c. Delete: Allows the investigator to delete a lab from their Form FDA 1572.
d. Provider Number: Displays the Provider Number of the lab.
e. Lab Name: Displays the name of the lab.
f. Lab Address: Displays the address of the lab.
g. Updated Action: Displays the latest status of the lab.
3. IRBs

a. Add New Record: Allows the investigator to manually search for and add
an IRB to their Form FDA 1572.
b. Populate IRBs: Allows the investigator to automatically add IRBs that are
associated to their selected practice site(s). If the practice site(s) are
covered by the NCI Central IRB (CIRB), all NCI CIRBs will be prepopulated.
c. Delete: Allows the investigator to delete an IRB from their Form FDA
1572.
d. IRB Number: Displays the IRB number.
e. IRB Name: Displays the name of the IRB.
f. IRB Address: Displays the IRB’s address.