VMMC-IRB Form 2-B: Registration and Application Form

REGISTRATION AND APPLICATION FORM

SECTION I: Application Information

1. Control No. VMMC-
2. Study Protocol
Title
3. Type of ☐ 2.1. Initial Review
Submission ☐ 2.2. Resubmission (responses to initial review recommendations or
submission of studies with investigator-initiated changes prior to
ethics approval).
NOTE: version and date of version must be inserted as a document footer
for all resubmissions
4. Date of Submission (to be filled up by VMMC-IRB)
5. Type of Study ☐ 5.1. Pre-clinical Research
☐ 5.2. Non-clinical trial, Specify: _________________________
(diagnostics, herbal research, review of medical records,
epidemiologic research, health informatics, etc)
☐ 5.2.1. Diagnostics
☐ 5.2.2. Herbal research
☐ 5.2.3. Complimentary and alternative medicine research
☐ 5.2.4. Review of medical records
☐ 5.2.5. Epidemiology study
☐ 5.2.6. Socio-behavioral research
☐ 5.2.7. Others (specify)
Others (specify): _____________________
☐ 5.3. Clinical Trial Type 1 (drug or pharmaceutical trials, diagnostic trials,
trials on devices, and other therapy trials) intended for marketing
registration
☐ 5.4. Clinical Trial Type 2 (drug or pharmaceutical trials, diagnostic trials,
trials on devices, and other therapy trials) NOT intended for
marketing registration
☐ 5.5. Post Marketing Surveillance
6. Category of ☐ 6.1. VMMC Physician, Full-time
Investigator ☐ 6.2. VMMC Physician, Part-time or Visiting
☐ 6.3. VMMC Training Fellow or Resident
☐ 6.4. Other VMMC employees, please specify _____________________
7. Purpose of study ☐ 7.1. Academic requirement (Thesis, Dissertation, Training Requirement)
☐ 7.2. Independent research work
☐ 7.3. Multi-institutional or multi-country collaboration
☐ 7.4. Others (indicate): ________________________________________
8. Study Protocol Please write synopsis (maximum 500 words) of the study in the space provided below
Synopsis based on the specific components, and indicate page where such components may be
found in the full study protocol or in annexes/ appendices. If items are not applicable,
indicate by N/A. Attach the full study protocol to this application.
Click here to enter text.
9. Study Duration Click here (in months)
10. Study Site
 VMMC-IRB Form 2-B: Registration and Application Form

11. Use of special ☐ YES ☐ NO

populations or ☐ 11.1. Children (under 18)
vulnerable groups ☐ 11.2. Indigenous people
☐ 11.3. Elderly*
☐ 11.4. People on welfare/social assistance
☐ 11.5. Poor and unemployed
☐ 11.6. Patients in emergency care
☐ 11.7. Homeless persons
☐ 11.8. Refugees or displaced persons
☐ 11.9. Patients with incurable diseases
☐ 11.10. Others (indicate)
☐ 11.11. Not applicable
*If the elderly age-group is the only subject population of the study; excludes
studies of diseases where the elderly may be predominantly selected by virtue
of prevalence of the disease in that age group
12. Funding Agency Name:
Type of Funding Agency:
13. Principal Investigator
14. PI Business <Institutional Address>
Address
15. PI Telephone/Fax
Nos.
16. PI Mobile No.
17. PI Email Address
18. Declaration on ☐ 18.1. I have no conflict of interest in any form (financial, proprietary,
Conflict of Interest professional) with sponsor, the study, Co-Investigator, or the site
for PI ☐ 18.2. I have personal/family financial interest in the results of the study
Nature:
☐ 18.3. I have proprietary interest in the research (patent, trademark,
copyright, licensing)
Nature:
19. Other investigators Name Contact Nos. E-mail Address
with corresponding Co-Investigator:
task description
(add additional Co-Investigator:
rows as applicable)
Study Coordinator:

20. Submitted by
Study designation
21. PI Signature
*Note: Please fill out this form electronically before printing.

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