|
|
|
|
GA |
100 |
GENERAL ADMINISTRATION |
|
|
101 |
Standard Operating Procedure (SOP) Preparation and Maintenance |
|
102 |
Document Development and Change Control |
|
103 |
Investigator Responsibility and Delegation of Responsibility |
|
104 |
Study Team Training |
|
105 |
Prohibition of Financial Conflicts |
|
RA |
200 |
REGULATORY AFFAIRS |
|
|
201 |
Contacts and Submissions for FDA |
|
|
202 |
Reporting Requirements for the FDA under an IND or IDE |
|
203 |
NIH Requirements for OBA-Reviewed Research |
|
PD |
300 |
PROTOCOL DEVELOPMENT |
|
301 |
Clinical Protocol Development, Implementation and Compliance |
|
302 |
Clinical Protocol Amendments |
|
303 |
Investigator’s Brochure |
|
|
|
|
SS |
400 |
STUDY START-UP |
|
|
401 |
Investigator Selection |
|
|
402 |
Initiation Visit |
|
|
|
|
PM |
500 |
PROJECT MANAGEMENT |
|
501 |
Communication |
|
502 |
Investigational Product Inventory Management |
|
503 |
Documentation and Records Retention |
|
504 |
Routine Monitoring Visits |
|
505 |
Study Closeout |
|
|
|
SM |
600 |
SUBJECT MANAGEMENT |
|
601 |
Informed Consent |
|
602 |
Subject Recruitment Practices |
|
|
603 |
Subject Screening and Enrollment |
|
|
604 |
Specimen Management |
|
|
605 |
Adverse Event Recognition and Reporting |
|
|
|
DM |
700 |
DATA MANAGEMENT |
|
701 |
Case Report Forms |
|
702 |
Clinical Research Data Management |
|
703 |
Use of Electronic Data Systems |
|
|
|
QA |
800 |
QUALITY ASSURANCE |
|
801 |
QA Audits |
|
802 |
FDA Inspection |
|
|
|
PP |
900 |
PRIVACY PRACTICES |
|
901 |
Safeguarding Personal Health Information |
|
902 |
Information Access Control |
|
|
|
