| Item |
Points |
Maximum Points Allowed Per Item |
Documentation Required for Verification (kept in personal files and listed on summary record) |
| 1) Proof of Continuing Involvement |
Requires 12 points each two years |
12 |
Proprietary information should be obliterated |
| Pharmaceutical Physician Activities |
| Participate in monitor meeting |
1 |
2 |
Report signature page |
| Participate in close out visit |
1 |
2 |
Report signature page |
| Authorship of protocol |
2 |
4 |
Protocal signature page |
| Medical monitor for clinical research trial |
1 |
3 |
Letter from supervisor |
| Service on DSMB or equivalent |
2 |
4 |
Letter from DSMB chair |
| FDA meeting attendance (regulatory) |
1 |
3 |
Invitation communication |
| Sponsor audit |
1 |
3 |
Report signature page |
| Physician Investigator Activities |
| Attend investigator meeting |
2 |
4 |
Copy invitation letter |
| Participate in initiation visit |
1 |
2 |
Report signature page |
| Authorship/review of clinical study report |
2 |
4 |
Report signature page |
| Inclusion on 1572 as active investigator |
1 |
3 |
Copy of 1572 (both sides) |
| Serve as director of research center |
12 per year |
12 |
Copy of appointment letter |
| Serve as compliance officer for institution |
12 per year |
12 |
Copy of appointment letter |
| Other (either/or) |
| Authorship of journal paper |
2 |
4 |
Journal citation including authors |
| Authorship of journal paper on clinical research |
2 |
4 |
Journal citation including authors |
| Continuing education presenter in clinical research or related topic |
2 |
4 |
Copy of program with speakers and objectives |
| Presentation of research at scientific meeting (regional, national, local) |
2 |
4 |
Presentation abstract including organization, locations and dates |
| Presentation at investigator's meeting |
2 |
4 |
Copy of program with speakers and objectives |
| Service on IRB |
3 |
3 |
Letter from IRB chair |
| Regulator document author/reviewer |
3 |
3 |
Document signature page |
| Service on item writing committee |
.5 points per question used |
4 |
Copy of contact hour certificate |
| Service on exam committee |
4 per day |
24 |
Copy of contact hour certificate |
| Service on scientific review of peer reviewed grants |
2 |
4 |
Report signature page |
| Peer reviewer of scientific articles |
1 |
3 |
Report signature page |
| 2) Proof of Continuing Education |
Requires 12 points each 2 years |
12 |
|
| CME hours |
1 per contact hour |
Maximum of 12, minimum of 1 |
Copy of contact hour certificate |
| CME related to clinical research |
4 per contact hour |
Maximum of 12, minimum of 4 |
Copy of contact hour certificate |
| FDA meeting attendance (educational) |
2 per contact hour |
12 |
Copy of contact hour certificate |
| Monitor Home Study |
3 per issue |
12 |
Copy of contact hour certificate |
| Other activities may be approved on a case-by-case basis by the CPI Exam Committee |