Trial Outcomes & Findings for Implementing Prescriber-Pharmacist Collaborative Care for Evidence-based Anticoagulant Use (NCT NCT05351749)
NCT ID: NCT05351749
Last Updated: 2026-03-30
Results Overview
Existing-prescription notification conditions = Prescriber notification \& Pharmacist notification The number of notifications (in the existing-prescription notification conditions) that are addressed within 7 days/ total number of notifications
COMPLETED
NA
306 participants
Up to 7 days
2026-03-30
Participant Flow
Assignment to conditions for alerts and notifications made upon first receiving either alert or notification. Receiving only alerts or only notifications de facto 'moves' participant to a new condition for only receiving alerts/only notifications. Similarly, if an alert/notification is deemed to not fit study criteria (e.g. if a patient hospitalized for any reason within 7 days of the alert), this may shift the participant's assignment as they no longer have both an alert and a notification.
Participant milestones
| Measure |
New-prescription Alert / Existing-prescription Notification to Prescriber
New-prescription Alert: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription.
Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Prescriber
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance.
Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
New-prescription Alert/ Existing-prescription Notification to Pharmacist
New-prescription Alert: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription.
Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Pharmacist
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance.
Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
New-prescription Alert/No Notifications
New-prescription Alert/No Notifications:
An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription.
No Notifications: Prescribers had no prescriptions that triggered a notification during the study period.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
New-prescription Alert w/Referral Option/No Notifications
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance.
No Notifications: Prescribers had no prescriptions that triggered a notification during the study period.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
No New-prescription Alert/Existing-prescription Notification to Prescriber
No New-prescription Alert: Prescriber had no prescriptions that triggered an alert Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
No New-prescription Alert/Existing-prescription Notification to Pharmacist
No New-prescription Alert: Prescriber had no prescriptions that triggered an alert Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
|---|---|---|---|---|---|---|---|---|
|
Allocation at Enrollment
STARTED
|
42
|
30
|
37
|
43
|
46
|
57
|
30
|
21
|
|
Allocation at Enrollment
COMPLETED
|
39
|
29
|
35
|
40
|
42
|
50
|
24
|
15
|
|
Allocation at Enrollment
NOT COMPLETED
|
3
|
1
|
2
|
3
|
4
|
7
|
6
|
6
|
|
Post Analysis of Alerts/Notifications
STARTED
|
39
|
29
|
35
|
40
|
46
|
53
|
24
|
16
|
|
Post Analysis of Alerts/Notifications
COMPLETED
|
39
|
29
|
35
|
40
|
46
|
53
|
24
|
16
|
|
Post Analysis of Alerts/Notifications
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
New-prescription Alert / Existing-prescription Notification to Prescriber
New-prescription Alert: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription.
Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Prescriber
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance.
Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
New-prescription Alert/ Existing-prescription Notification to Pharmacist
New-prescription Alert: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription.
Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Pharmacist
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance.
Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
New-prescription Alert/No Notifications
New-prescription Alert/No Notifications:
An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription.
No Notifications: Prescribers had no prescriptions that triggered a notification during the study period.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
New-prescription Alert w/Referral Option/No Notifications
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance.
No Notifications: Prescribers had no prescriptions that triggered a notification during the study period.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
No New-prescription Alert/Existing-prescription Notification to Prescriber
No New-prescription Alert: Prescriber had no prescriptions that triggered an alert Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
No New-prescription Alert/Existing-prescription Notification to Pharmacist
No New-prescription Alert: Prescriber had no prescriptions that triggered an alert Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
Note: inclusion in this group is predicated on the prescriber receiving at least one notification and one alert that meet criteria for inclusion in analysis by the end of the trial period.
|
|---|---|---|---|---|---|---|---|---|
|
Allocation at Enrollment
Moved to another arm based on actual hospital experience
|
2
|
1
|
2
|
3
|
0
|
0
|
0
|
0
|
|
Allocation at Enrollment
Participants dropped from the analysis (because patients no longer fit criteria)
|
1
|
0
|
0
|
0
|
4
|
7
|
6
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
New-prescription Alert/ Existing-prescription Notification to Pharmacist
n=37 Participants
New-prescription Alert: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription.
Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
|
New-prescription Alert / Existing-prescription Notification to Prescriber
n=42 Participants
New-prescription Alert: An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription.
Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
|
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Prescriber
n=30 Participants
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance.
Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
|
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Pharmacist
n=43 Participants
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance.
Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
|
New-prescription Alert/No Notifications
n=46 Participants
New-prescription Alert/No Notifications:
An enhanced drug alert notification in the Michigan Medicine electronic health record (EHR) that is tailored to the specific type of inappropriate Direct Oral Anticoagulant (DOAC) use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter a newly prescribed DOAC prescription.
No Notifications: Prescribers had no prescriptions that triggered a notification during the study period.
|
New-prescription Alert w/Referral Option/No Notifications
n=57 Participants
New-prescription Alert with referral option: An enhanced drug alert notification in the EHR that is tailored to the specific type of inappropriate DOAC use (e.g., dosing too high for renal dysfunction) and offers decision support to the prescriber to alter new DOAC prescription. This alert will ALSO include an option for referral to the anticoagulation clinic pharmacist for assistance.
No Notifications: Prescribers had no prescriptions that triggered a notification during the study period.
|
No New-prescription Alert/Existing-prescription Notification to Prescriber
n=30 Participants
No New-prescription Alert: Prescriber had no prescriptions that triggered an alert
Existing-prescription notification to prescriber: Prescriber receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
|
No New-prescription Alert/Existing-prescription Notification to Pharmacist
n=21 Participants
No New-prescription Alert: Prescriber had no prescriptions that triggered an alert
Existing-prescription notification to pharmacist: Pharmacist receives a notification through the EHR indicating an existing DOAC prescription may not be appropriate (e.g. due to renal function change, new drug-drug interactions), and recommending a prescription update.
|
Total
n=306 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Age >= 18 years
|
37 Participants
n=37 Participants
|
42 Participants
n=42 Participants
|
30 Participants
n=30 Participants
|
43 Participants
n=43 Participants
|
46 Participants
n=46 Participants
|
57 Participants
n=57 Participants
|
30 Participants
n=30 Participants
|
21 Participants
n=21 Participants
|
306 Participants
n=306 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=37 Participants
|
27 Participants
n=42 Participants
|
19 Participants
n=30 Participants
|
25 Participants
n=43 Participants
|
26 Participants
n=46 Participants
|
37 Participants
n=57 Participants
|
22 Participants
n=30 Participants
|
14 Participants
n=21 Participants
|
191 Participants
n=306 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=37 Participants
|
15 Participants
n=42 Participants
|
11 Participants
n=30 Participants
|
18 Participants
n=43 Participants
|
20 Participants
n=46 Participants
|
20 Participants
n=57 Participants
|
8 Participants
n=30 Participants
|
7 Participants
n=21 Participants
|
115 Participants
n=306 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
37 participants
n=37 Participants
|
42 participants
n=42 Participants
|
30 participants
n=30 Participants
|
43 participants
n=43 Participants
|
46 participants
n=46 Participants
|
57 participants
n=57 Participants
|
30 participants
n=30 Participants
|
21 participants
n=21 Participants
|
306 participants
n=306 Participants
|
|
Clinical Role
House Officer
|
3 Participants
n=37 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=43 Participants
|
10 Participants
n=46 Participants
|
9 Participants
n=57 Participants
|
6 Participants
n=30 Participants
|
3 Participants
n=21 Participants
|
33 Participants
n=306 Participants
|
|
Clinical Role
Primary Care Clinician
|
21 Participants
n=37 Participants
|
29 Participants
n=42 Participants
|
18 Participants
n=30 Participants
|
30 Participants
n=43 Participants
|
13 Participants
n=46 Participants
|
22 Participants
n=57 Participants
|
13 Participants
n=30 Participants
|
9 Participants
n=21 Participants
|
155 Participants
n=306 Participants
|
|
Clinical Role
Specialty Care Clinician
|
13 Participants
n=37 Participants
|
13 Participants
n=42 Participants
|
11 Participants
n=30 Participants
|
12 Participants
n=43 Participants
|
23 Participants
n=46 Participants
|
26 Participants
n=57 Participants
|
11 Participants
n=30 Participants
|
9 Participants
n=21 Participants
|
118 Participants
n=306 Participants
|
PRIMARY outcome
Timeframe: Up to 7 daysPopulation: Participants analyzed for this outcome all received an existing prescription notification (randomized to prescriber vs pharmacist recipient), regardless of if that participant was exposed to a new medication alert.
Existing-prescription notification conditions = Prescriber notification \& Pharmacist notification The number of notifications (in the existing-prescription notification conditions) that are addressed within 7 days/ total number of notifications
Outcome measures
| Measure |
Notification Sent to Prescriber
n=92 Participants
All notifications sent to prescriber participants across all alert conditions
|
Notification Sent to Pharmacist
n=91 Participants
All notifications sent to pharmacist participants across all alert conditions
|
|---|---|---|
|
The Number (Proportion) of Notifications (in the Existing-prescription Notification Conditions) That Are Addressed Within 7 Days.
|
24.86 percent of notifications
|
21.74 percent of notifications
|
SECONDARY outcome
Timeframe: Up to 7 daysPopulation: Participants analyzed for this outcome all received a new prescription alert (randomized to include or not include a pharmacist referral option), regardless of if that participant was exposed to an existing prescription notification.
Newly prescribed DOAC alert conditions= Medication alert \& Medication alert + referral Data reported represents the number of alerts (in the newly prescribed DOAC alert conditions) that are addressed within 7 days/ total number of alerts
Outcome measures
| Measure |
Notification Sent to Prescriber
n=120 Participants
All notifications sent to prescriber participants across all alert conditions
|
Notification Sent to Pharmacist
n=122 Participants
All notifications sent to pharmacist participants across all alert conditions
|
|---|---|---|
|
The Number (Proportion) of Alerts (in the Newly Prescribed DOAC Alert Conditions) That Are Addressed Within 7 Days.
|
29.84 percentage of alerts
|
29.10 percentage of alerts
|
SECONDARY outcome
Timeframe: Month 0 to 19 monthsReported on at the institution level (not individual level). Existing-prescription notification conditions = Prescriber notification \& Pharmacist notification The number of notifications (in the existing-prescription notification conditions) that are addressed within 7 days/ total number of notifications, shown over multiple time periods. This outcome measure analysis is based on the results of outcome #1.
Outcome measures
| Measure |
Notification Sent to Prescriber
n=203 Participants
All notifications sent to prescriber participants across all alert conditions
|
Notification Sent to Pharmacist
All notifications sent to pharmacist participants across all alert conditions
|
|---|---|---|
|
Change in Effect Size for the Existing-prescription Notification Over Time
Months 0-6
|
17.58 percent of notifications
|
—
|
|
Change in Effect Size for the Existing-prescription Notification Over Time
Months 7-12
|
27.95 percent of notifications
|
—
|
|
Change in Effect Size for the Existing-prescription Notification Over Time
Months 13-19
|
25.81 percent of notifications
|
—
|
SECONDARY outcome
Timeframe: Month 0 to 19 monthsPopulation: Out of 255 participants who received alerts, 13 participants' data was determined to be ineligible
Reported on at the institution level (not individual level). Newly prescribed DOAC alert condition= Medication alert \& Medication alert + referral The number of new prescription alerts that are addressed within 7 days/ total number of alerts, shown over multiple time periods. This outcome measure analysis is based on the results of outcome #2.
Outcome measures
| Measure |
Notification Sent to Prescriber
n=242 Participants
All notifications sent to prescriber participants across all alert conditions
|
Notification Sent to Pharmacist
All notifications sent to pharmacist participants across all alert conditions
|
|---|---|---|
|
Change in Effect Size for the Initial Alert Over Time
7 -12 months
|
28.47 percentage of alerts
|
—
|
|
Change in Effect Size for the Initial Alert Over Time
0-6 months
|
30.06 percentage of alerts
|
—
|
|
Change in Effect Size for the Initial Alert Over Time
13 - 19 months
|
29.63 percentage of alerts
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days from alert or notificationData was gathered from the patients of participants within 30 days of a notification being sent via post-hoc examination of electronic medical record data Clinical adverse events assessed will include major 21 and clinically-relevant non-major bleeding (CRNMB)22 events, as defined by the International Society on Thrombosis and Haemostasis (ISTH), new or recurrent VTE events, and stroke or systemic arterial embolic events. Each of these events will be captured using health informatics tools (described below) and independently adjudicated by two expert clinicians (one pharmacist, one prescriber) who meet once in Y1 and twice in Y2 to adjudicate any potential adverse events. We will use two Michigan Medicine-developed health informatics tools, DataDirect and EMERSE,23 to identify adverse events and capture clinical data (e.g., notes, labs, imaging, procedure reports) for adjudication.
Outcome measures
Outcome data not reported
Adverse Events
New-prescription Alert / Existing-prescription Notification to Prescriber
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Prescriber
New-prescription Alert/ Existing-prescription Notification to Pharmacist
New-prescription Alert w/ Referral Option/ Existing-prescription Notification to Pharmacist
New-prescription Alert/No Notifications
New-prescription Alert w/Referral Option/No Notifications
No New-prescription Alert/Existing-prescription Notification to Prescriber
No New-prescription Alert/Existing-prescription Notification to Pharmacist
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place