| 1 |
Additional education; |
| 2 |
Design changes in processes; |
| 3 |
Notification of Study Participants of issues/problems with the study; |
| 4 |
Enhanced external monitoring with direct review on areas of concern; |
| 5 |
Observation of processes by external observers; |
| 6 |
External intervention (i.e., “Preceptorship” or “Receivership”) |
| 7 |
Suspension of study; |
| 8 |
Suspension of researcher privileges to conduct research; |
| 9 |
Termination/Revocation of researcher privileges to conduct research; and, |
| 10 |
Study termination. |
