Attachment |
Title |
Change |
Notes |
Attachment A – List of CTSU Forms |
A01 |
IRB Transmittal |
Revised |
2023 Revision |
A22 |
Compliance, Learning, and SOP Solutions (CLASS) Course Setup Request Form |
Revised |
2023 Revision |
A23 |
LPO Approval of Early Study Closure |
New |
2023 Revision |
A24 |
Electronic Signature Form – International |
New |
2023 Revision |
Attachment B – List of NCI CIRB Forms / Documents |
B10 |
CIRB IR Application |
Revised |
2023 Revision |
B12 |
CIRB AR RecMat Application |
Revised |
2023 Revision |
B33 |
Application for Translation Review |
Revised |
2023 Revision |
B50 |
Final Video Submission Posting Form |
New |
2023 Revision |
B52 |
Unanticipated Problem or Serious or Continuing Noncompliance Application |
New |
2023 Revision |
For the Surveys |
C03 |
OPEN Survey |
Removed |
2023 Revision |
Attachment E – Pharmaceutical Management Branch Forms |
E05 |
Non-IND/Non-Treatment Investigator Registration Form |
New |
2023 Revision |
E06 |
International Investigator Statement (IIS) Form |
New |
2023 Revision |
Attachment F – CTEP form for central database submissions |
F01 |
Basic Study Information Form (Attachment TBD) |
New |
2023 Revision |