Principal Investigator and Research Site

PRINCIPAL INVESTIGATOR AND RESEARCH SITE

submission form

Date: eMedicus IRB Protocol #______

(Internal Use Only)

Complete this form for each Principal Investigator and Research Site submitted to the eMedicus Institutional Review Board. All information must be completed and the form must be signed by the Principal Investigator prior to submission. Refer to the HIPAA Section of the eMedicus IRB website for the Authorization Form, and the Waiver Form.

Protocol Information

Title of Protocol:
Sponsor Protocol Number:
Version Number and Date of Protocol:
1. / Principal Investigator Information:
Please provide information about the person who will be legally responsible for the conduct of this research study. eMedicus IRB must be assured that the investigator can oversee both the Conduct of Research and the Protection of Human Subjects [21 CFR 56.102 (h)]
1a / Principal Investigator Name:
1b / Name of Research Site:
Street Address:
1c / City: / State/Province: / Zip Code: / Country:
1d / Principal Investigator Phone:
() - Extension: / Principal Investigator Fax:
() - / Principal Investigator Email:
1e / Principal Investigator Degree(s):
Check all that apply:
MD DO PhD MBA MPH MPA Other, please specify:
1f / Principal Investigator Board Certification(s) and Specialty:
Board Certification: Area of Specialty: / NA
2. / Principal Investigator Licensing Information
Please complete the information requested and attach legible copies of all current licenses and registrations.
Please enlarge copies for legibility as necessary.
2a / Medical License #: / State / Province: / Expiration Date: / NA
2b / DEA Registration # : / Expiration Date: / NA
2c /

For Massachusetts and California Physicians ONLY:

/

NA

State: Massachusetts California

/

Research License #:

/

Expiration Date:

3. /

State Specific Research Requirements

3a / Are there specific State or Local Laws governing Research in your State or Province?
* If No, proceed to Section 4. / Yes / *No
3b / Indicate any State or Local Laws governing Research that will impact this research study at your site.
Mandatory IRB Site Visits Age of Majority 19
Florida Advertisement Disclaimer California Experimental Bill of Rights
State Privacy Laws related to the use of Protected Health Information (PHI)
Other, please specify:
4. /

Principal Investigator MANAGEMENT

4a / How many years has the Principal Investigator been conducting clinical research?
4b / How many of the following are currently supervised by the Principal Investigator?
Research studies:
Research subjects:
Sub-investigators: / Research Coordinators/ Nurses:
Sites:
4c / How many of the following are currently supervised by the Principal Investigator at this site?
Research studies:
Research subjects:
Sub-investigators: / Research Coordinators/ Nurses:
Sites:
4d / In how many other research studies is the current Principal Investigator listed as a Sub-investigator?
4e / Indicate below how the Principal Investigator plans to provide oversight and supervision for the conduct of this study at the primary site and any other additional site locations:
Check all that apply:
Research Team Meetings
Meetings with Study Sponsor or their representatives
Delegation of Authority Log
Other, please specify:
*If your site has an SOP for the conduct and supervision of research studies, please attach.
5. /

clinical research coordinator information

5a / Research Coordinator Name:
5b / Research Coordinator Phone:
() - Extension: / Research Coordinator Fax:
() - / Research Coordinator Email:
5c / How many years has the Research Coordinator been involved in clinical research?
0–1 year 2–5 years 6–10 years More than 10 years
6. / compliance / legal information
6a / Has the Principal Investigator, any investigator(s) associated with this research study, or the research site been audited by any of the following agencies within the last 5 years:
a.  Office of Human Research Protections (OHRP)
b.  FDA
* If Yes, provide details in the space provided and submit all audit-related correspondence including, but not limited to, the FDA Form 483 and the investigator’s/ site’s response: / *Yes
*Yes / No
No
6b / Has the Principal Investigator or any investigator(s) associated with this research study ever received any of the following:
a.  FDA Warning Letter
b.  NIDPOE (Notification of Initiation of Impending Disqualification Procedures
and Opportunity to Explain)
* If Yes, indicate the year: / *Yes
*Yes / No
No
6c / Has the Principal Investigator or any investigator(s) associated with this research study ever received any of the following:
a.  Sanctioned by a Federal or State Regulatory Agency
b.  Had a study terminated by a Federal or State Regulatory Agency
* If Yes, provide details: / *Yes
*Yes / No
No
6d / Has the Principal Investigator or any investigator(s) associated with this research study ever had any of the following actions imposed by any IRB?
a.  Study terminated
b.  Study suspended
c.  Restrictions or Sanctions
d.  Refusal to review a research study
* If Yes, provide details: / *Yes
*Yes
*Yes
*Yes / No
No
No
No
6e / Has the Principal Investigator or any investigator(s) associated with this research study ever been charged or sanctioned by a State Medical Board which resulted in any of the following regarding their license to practice medicine:
a.  Suspended
b.  Revoked
c.  Placed on Probation
d.  Restrictions
* If Yes, please provide details; / *Yes
*Yes
*Yes
*Yes / No
No
No
No
6f / Has the Principal Investigator or any investigator(s) associated with this research study ever been convicted of a misdemeanor or felony that was related to the Practice of Medicine?
* If Yes, please provide details: / *Yes / No
7. / Regulatory INFORMATION
7a / Please attach a signed copy of U.S. FDA Form 1572 if applicable.
7b / Has another IRB reviewed, disapproved, or terminated this research study at your site prior to submission to eMedicus IRB?
* If Yes, provide the IRB correspondence. / *Yes / No
7c / Is this research study being transferred to eMedicus IRB from another IRB?
* If Yes, please complete the IRB Transfer Form. / *Yes / No
7d / Are you under the jurisdiction of a local IRB?
* If Yes, you will need to complete an IRB Waiver Form. / *Yes / No
8. / Investigational New Drug / Biologic OR INVESTIGATIONAL USE OF A MARKETED DRUG OR BIOLOGIC
8a / Does this research study involve the use of an Investigational New Drug/Biologic or Investigational use of a Marketed Drug(s) or Biologic(s)?
* If No, proceed to Section 9. / Yes / *No
8b /

Will drug be provided to research subjects in this study free of charge?

/ Yes / No
8c / Will Investigational New Drug/Biologic be stored and dispensed at this study site? / Yes / No
8d / Who will be responsible for the storage and accountability of the Investigational New Drug/Biologic?
Site Principal Investigator Pharmacy Other, please specify:
9. / Investigational Device Information
9a / Does this research study involve the use of an Investigational Device?
* If No, proceed to Section 10. / Yes / *No
9b /

Will a free device be provided to research subjects in this study?

/ Yes / No
9c /

Who will be responsible for the storage and inventory of the Investigational Device?

Site Principal Investigator Pharmacy Other, please specify:
9d /

Who will be responsible for the accountability of the Investigational Device?

Site Principal Investigator Pharmacy Other, please specify:
10. / RESEARCH SITE DESCRIPTION
10a / Please indicate the type of facility where the research will be conducted:
Community Hospital University Hospital Clinic affiliated with Hospital
Free-standing Clinic Private Physician Office Free-standing Research Facility
Cancer Center Other, please specify:
10b / Does the research site have adequate staff and equipment, including the availability of emergency equipment, to conduct this research study?
*If No, please explain why: / Yes / *No
11. / EMERGENCY MEDICAL MANAGEMENT
11a / How close is the nearest hospital with emergency facilities?
0–1 mile 2–5 miles 6–10 miles 11–15 miles Greater than 15 miles
11b / What is the name of the nearest hospital to be used in the event of an emergency?
11c / Does the Principal Investigator of Sub-investigator(s) have staff privileges at the emergency facility listed in 11b? / Yes / No
11d / What types of Emergency Resources are available at the site where the research will be conducted?
Check all that apply:
Crash Cart Defibrillator Emergency Medications Call 911
Emergency Response Team within facility Other, please specify:
11e / Indicate the type of training the Principal Investigator, Sub-investigators, and the research/office staff have in treating emergencies?
Check all that apply:
CPR Certified Advanced Cardiac Life Support (ACLS) Certified Other, please specify:
12. /

community and cultural perceptions of research

12a / Indicate the attitude towards research in the community from which your site will recruit research subjects.
Positive Neutral * Negative * Other
* If Negative or Other, please explain:
12b / Has there been any recent media focus on research in your community?
* If Yes, please explain: / *Yes / No
12c / What are the primary language(s) fluently spoken in the community / practice from which your research site recruits research subjects?
English Spanish French Other, please specify:
12d / Indicate the average educational level of the community / practice from which your research site recruits research subjects:
8th grade or below High School / GED College Other, please specify:
13. /

Recruitment of Research Subjects

13a / Approximately how many research subjects does the Principal Investigator expect to enroll in this research
study?
13b / What type of research subjects will be recruited for this research study?
Check all that apply:
Newborns / Infants Normal Volunteers Prisoners
Children (Age 2-12) Pregnant Women Students
Adolescents (Age 13-17) Mentally Disabled
Adults (Age 18-64) Employees
Adults (Age 65+) Other, please specify:
13c / Indicate all individuals who are authorized to perform screening of patients to determine their eligibility for the research study: / NA
13d / Will research subjects from “vulnerable” categories be enrolled in this research study?
* If No, proceed to Section 13f. / Yes / *No
13e / Check all “vulnerable” research subject categories that apply to this research study:
Mentally Disabled Nursing Home Residents Handicapped
Institutionalized Chronic Condition Terminally Ill
Hospitalized Pregnant Women Prisoners
Indigent Populations Minors Employees / Staff of Research Site
Students Life threatening conditions
Other Populations Vulnerable to Coercion, please specify:
13f / Which of the following methods will the Principal Investigator use to recruit research subjects for this research study?
Check all that apply:
Primary Physician Inpatients Printed Advertisements Email Announcements
Emergency Room Referrals Radio / TV Advertising Internet Sites
Outpatient Clinics Doctor to Doctor Letter
Other, please specify:
13g / Do you plan to pay “referral fees” or “finder’s fees” to other physicians for recruitment of research subjects for this study?
* If Yes, please answer the following questions: / *Yes / No
Why is a “referral fee” or “finders fee” necessary for recruitment for this study?
Who will receive the payment?
How much will the payment be?
13h / Indicate the racial and ethnic composition of the community where research subjects will be recruited for this research study:
Numbers in each category MUST add up to 100%
Race / Ethnicity
% Black or African American
% White or Caucasian
% American Indian/Alaskan Native
% Asian
% Native Hawaiian/Pacific Islander
% Other, please specify
100 % TOTAL / % Hispanic or Latino
% Not Hispanic or Latino
100 % TOTAL
14. / Advertisements
14a / Will any type of advertising materials be utilized to recruit research subjects for this study?
* If No, proceed to Section 15. / Yes / *No
14b / Please attach a copy of the recruitment materials and indicate the type.
Check all that apply.
* For Radio / TV and Public Service Announcements submit script for pre-review prior to recording.
Brochure * Newspaper Advertising Internet Sites
Direct Mailing * Radio / TV Advertising Email Announcements
Postings * Public Service Announcements
Other, please specify:
15. /

Informed Consent process

15a / Will the informed consent discussion with the research subject take place in a private area in your facility?
* If No, please explain: / Yes / *No
15b / Indicate all individuals who are authorized to conduct the informed consent discussion with the research subject:
Principal Investigator Nurse Practitioner Residents / Fellows
Co-Investigator Research Nurse Staff Physicians
Physician Assistant Study Coordinator Other, please specify:
* All research personnel that obtain informed consent MUST be included on the FDA Form 1572.
15c / What measures will be used to minimize the potential for coercion or undue influence?
Check all that apply:
Potential research subjects who decide not to participate in the research study will not be threatened with harm or negative consequences.
During the informed consent process, all study information will be presented to research subjects in an unbiased fashion. The potential benefits and risks associated with the study will be discussed with equal emphasis.
Other, please specify:
15d / Will research subjects be given the opportunity to take the Informed Consent Form home to review prior to signing it? / Yes / No
15e / When will the informed consent be obtained by the research subject?
Immediately prior to the study
Next office visit / 24+ hours prior to the study
Other, please specify:
15f / Is the Principal Investigator or the designee available to answer any questions the research subject may have during the informed consent process?
* If No, please explain: / Yes / *No
15g / Will a copy of the signed informed consent document be given to the research subject?
* If No, please explain: / Yes / *No
15h / Will all research subjects speak English?
* If Yes, proceed to Section 17. / *Yes / No
16. / Informed Consent Process – Non English Speaking Research Subjects
16a / Indicate the language of non-English speaking research subjects the Principal Investigator plans to enroll in this research study:
Spanish Indian Chinese Italian French Portuguese Japanese
Other, please specify:
16b / Would you like eMedicus IRB to provide Certified Translation of the approved Informed Consent?
* If Yes, there is an additional fee for this service and a turnaround time of 5-7 days.
* If Yes, please specify the language(s) requested: / *Yes / No
16c / Is the Principal Investigator or any of the research staff bilingual?
* If Yes, please indicate whom and specify the language spoken: / *Yes / No
Principal Investigator Language:
Co-Investigator Language:
Staff Physicians Language:
Residents / Fellows Language: / Nurse Practitioner Language:
Research Nurse Language:
Study Coordinator Language:
Other, please specify:
17. /

Informed Consent Process – LEGALLY AUTHORIZED REPRESENTATIVE (lar)