| 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 |