Business Requirements
- If a study has one or more Investigational New Drugs, the Coordinator must provide the FDA assigned number for each in PB if available.
- If a study is exempt, no IND numbers or Holder names are required.
- If the Holder is available in the PB, the coordinator will include them there as a Sponsor and made available in CRC2 to select.
- If the Holder is not available in PB, CRC2 will allow the Coordinator to...
- Select from UVA LDAP entries if the Holder is a UVA PI
- Enter as free text if Holder is not a UVA PI or the UVA PI was not found in LDAP
- If applicable, the IND Holder Type will be specified as:
- Industry
- UVA PI
- Other PI
- Other Colleges and Universities
- The Coordinator will provide the biologic drug name for each IND, if available.
- The IND numbers are not always available during the initial completion of the PB, and do not need to be available for the IRB pre-review, but must be available at the time of final submission to the IRB unless the study is exempt. In a scenario where the submission was accepted with one or more missing IND #s IRB personnel will enter them as received in their system and updating PB/CRC2 is not required.
Protocol Builder Interface
If Coordinators specify in PB an Investigational New Drug is used in the study, the IRB API Details variable IS_IND is set to 1 (true). If true, PB provides fields to enter up to three IND #s, if they are available, in the IRB API Details variables IND_1, IND_2 and IND_3. The Coordinator is also asked if the drug was developed at UVA, and if so, the IRB API Details variable IS_UVA_IND is set to 1 (true).
The Coordinator should also enter in PB the Holder of each IND number as a Sponsor.
CRC1 Stats
A 7/20/2020 analysis of IND data in CRC1 indicated 40% of 293 studies had IS_IND = 1. Of those, 91 had an IND_1 number entered, 1 had an IND_2 number entered and none had an IND_3 number entered.
Study Dashboard Menu Dependencies
| State | Condition |
|---|---|
| Required | IRB API Details variable IS_IND is 1 |
| Hidden | IRB API Details variable IS_IND is 0 or Null |
Workflow Description
In the Load IND Data script task the variables IS_IND, IND_1, IND_2, IND_3 and IS_UVA_IND are pulled from the IRB API Details endpoint. Additionally, the list of PB Sponsors is configured into enum dropdown format to be used for indicating the IND holder.
These variable are then passed through two decision tables, IND Number Check and UVA IND Check. The IND Number Check decision table determines if there were any IND numbers entered in PB and if not, the study is defaulted to be Exempt. For each IND_n variable the default for the Holder Type dropdown is set to "" if there is a number and NA if there is no number entered. The UVA IND Check decision table converts the PB results if 1 or 0 to True or False, respectively.
The IS_IND? exclusive gateway checks to see if the IS_IND variable from PB was converted to True and if so, continues with the workflow. If not, it takes the Coordinator to the Show Contact Support manual task which informs the Coordinator that they should not be in this workflow and instructs them to contact support. This should only occur if there is a failure of the menu logic.
The Confirm IND Status user task allows the coordinator to confirm or change the interpretation of the information pulled from PB and add additional information about each drug, which includes the holder type and drug/biologic name. If the IND Number Check determines that the study might be exempt, a question to confirm or refute the assumption is provided. Another confirmation for each IND in this task if whether the holder was included as a sponsor in PB, which is used in the next sections to determine if a selection from the PB Sponsors, a selection from UVA LDAP or free text is how the holder name will be provided.
If the study is not exempt and a holder name is needed, there is a section for each IND to determine how that name will be provided:
- Selected from the list of sponsors pulled rom PB
- Option provided if the Coordinator indicated in the Confirm IND Status user task that the holder was added as a PB Sponsor
- The option to enter as text is provided if the Coordinator was mistaken and the holder was not found in the PB Sponsor list
- Selected from UVA's LDAP registry if not entered as a PB Sponsor and holder type is UVA PI
- The option to enter as text is provided if the Coordinator was not found in the UVA LDAP search
- Entered as text if not entered as PB Sponsor and holder type not UVA PI
- Script tasks to configure the text entry user task, if needed, to mimic the enum format so the output is in a consistent format.
Documents
No documents are produced from this workflow. The CTO office enters the workflow and reviews by stepping through the forms.