/ Phase I Healthy Participant Studies:
Generic Screening Consent Form Questionnaire /
Please use this form when submitting a generic screening consent form for Phase I Healthy Participant studies.
For the purposes of IRB review, one (1) Principal Investigator must oversee the use of a generic screening consent form at the site.
Any doctor or qualified employee at the site (as determined by the Principal Investigator) may administer the use of a generic screening consent form.
1. PRINCIPAL INVESTIGATOR FOR SCREENING PURPOSES (Provide the PI’s name as it should appear on all Quorum issued documentation.)
FIRST NAME: / MIDDLE INITIAL: / LAST NAME: / SUFFIX:
MEDICAL/PROFESSIONAL LICENSE#(S): / STATE(S): / EXPIRATION DATE(S) (MM/DD/YY):
EMAIL: / CLIENT CONTROL # (if applicable):
Please submit a copy of the PI’s CV.
2. SCREENING FACILITY (The phone numberlisted below will be included on your generic screening consent form. If you would like your address to appear on the generic screening consent form, include it in the content of your submitted consent form.)
FACILITY OR BUSINESS NAME:
ADDRESS:
CITY: / STATE: / ZIP/POSTAL CODE:
PHONE:
3. COMMUNICATION WITH AND FROM QUORUM REVIEW (Primary Contact)
Please indicate the primary contact for Board communication about this generic screening consent form. (Examples of Board communication will include follow-up about incomplete/unclear form answers, Board requests for additional information, etc.)
PRIMARY CONTACT NAME:
FACILITY OR BUSINESS NAME:
MAILING ADDRESS:
CITY: / STATE/PROVINCE: / ZIP/POSTAL CODE:
PHONE: / EMAIL:
Official Quorum documentationwill be provided via a Quorum Web Portal account (at no cost). Through the Portal, users can access approval documents and make secure electronic submissions.
If you require hard copy delivery, please contact Quorum at (206) 448-4082 to arrange prepayment of annual fee.
4. BILLING CONTACT (Electronic invoices will be sent to the Billing Contact. Invoicing questions will be directed to the Accounting Contact.)
a.BILLING NAME: / TITLE:
COMPANY:
ADDRESS:
CITY: / STATE/PROVINCE: / ZIP/POSTAL CODE: / COUNTRY:
BILLING PHONE: / BILLING EMAIL:
b. ACCOUNTING CONTACT NAME:
ACCOUNTING CONTACT PHONE: / ACCOUNTING CONTACT EMAIL:
5. SCREENING PLAN
a. Please attach a copy of the screening plan. If you do not have a separate screening plan, please describe your site’s screening process, including:
  • How participants will be recruited
  • Which screening procedures will be conducted
  • Type of facility where screening occurs
  • Qualifications of staff that perform screening procedures
  • Whether participants are screened in a private or group setting
  • How information will be maintained if participants are not eligible for a study, decline participation, or fail the screening

Fasting and Wash Out
b.Will participants be required to fast or wash out medications prior to providing written informed consent for screening?
Note: The FDA requires consent be obtained prior to requesting participantsto engage in any research activities, such as fasting or washing out medications.
NO
YES. If yes, please submit the following:
1). F-042, Waiver of Documentation of Informed Consent Submission Form
2). A script to obtain consent verbally (typically by phone) for the requested activity prior to signing the informed consent for screening
OR describe your alternative plan to obtain informed consent prior to requesting participants to fast or washout medications:
6. INFORMATION ABOUT THE PRINCIPAL INVESTIGATOR
All investigators must include the documents listed below (as applicable) as attachments to this form.
a.Has the Principal Investigator been audited or received disciplinary action by a sponsor, Ethics Review Board, Institution, or other entity?
NO (Skip to question 7 below)
YES(Please answer the below questions)
b.Has the FDA, OHRP, the Canadian Ministry of Health, or other regulatory agency audited the screeningPrincipal Investigator only within the last 3 years? Copies of all audit documentation (such as Establishment Inspection Reports, Form FDA 483s, warning letters and corresponding investigator responses) issued within the last 3 years must be included with this submission.
NO
YES, audit(s) have occurred(check all that apply):
Documentation is attached for audit(s)
Documentation is not yet available (will be submitted to Quorum as soon as available)
Documentation has been previously submitted for audit(s) dated: (MM/DD/YY)
c.Has the FDA, OHRP, the Canadian Ministry of Health, or other local licensing authority ever taken action against the Principal Investigator, including issuing a reprimand, restricting his/her ability to conduct research, or placing conditions on or otherwise limiting his/her license?
NO
YES.If so,please explain orattach a letter of explanation:
d.Has research under the Principal Investigator’s oversight been suspended or terminated by a sponsor, Ethics Review Board, Institution, or other entity?
NO
YES. If so,please explain or attach a letter of explanation:
7. HUMAN RESEARCH PARTICIPANT PROTECTION TRAINING
Principal Investigator Experience
a. Does the Principal Investigator have clinical research experience with human participants?
NO
YES
Principal Investigator Training
b. Indicate whathuman research participant protection trainingthe PI has completed within the past 3 years(check all that apply):
Review of all the FDA Information Sheets, GCP Guidelines, and The Belmont Report.
Completion of the CITI Program: Course in the Protection of Human Research Subjects (available through Quorum
Review).
Completion of theNational Institutes of Health (NIH) Training: NIH Clinical Center Clinical Research TrainingorNIH Office of Extramural Research Protecting Human Research Participants Training.
Completion of other seminar or on-line training specific to human research participant protection.
Completion of self-study specific to human research participant protection(check all that apply):
Investigators Meeting
Clinic/CRO/SMO Training
Other (e.g. Web Based HRPP training please describe or identify course/title):
The PI has not completed any training on human research participant protection. This will be addressed through the following: (check all that apply)
Investigators meeting
Clinic/CRO/SMO training
Other (e.g. Web Based HRPP training). Please describe or identify course/title:
Staff Training
c.Quorum requires that screeningstaff and key personnel at this facility have been trained and are aware of their obligations with regard to human research participant protection regulations.
If this training has not occurred,please explain or attach a letter of explanation:
8. EMERGENCY MEASURES
Does the screening facility have CPR certified staff and access to 911?
NO. If not, please explain what emergency measures will be used:
YES
9. LOCAL JURISDICTION ISSUES
Please mark all local jurisdiction issues below that apply.
Local Jurisdiction Issue / Required Attachment (if box is checked)
All forms available at quorumreview.com or by contacting your Study Manager
One or more of the screening activities will be conducted in a facility that is under the jurisdiction of another Ethics Review Board (for example, an MRI performed at a local university). /
  • Quorum Review Institutional Jurisdiction WaiverForm OR Institutional Cover Page (if available)

Another Ethics Review Board or Institution (hospital, university, etc.) maintains jurisdiction over the Principal Investigator and screening activities (for example, the PI is on the faculty of a local university). /
  • Quorum Review Institutional Jurisdiction WaiverForm OR Institutional Cover Page (if available)

I am aware of State, provincial, or other local laws governing research that impose obligations that Quorum should be aware of. /
  • Description
  • Copies of the applicable laws, if available

I am aware of local issues of note that may adversely impact the screening activitiesconducted at this facility (recent or historic events related to screening or research in this community, institutional features, etc.). /
  • Letter of explanation

10. PRIVACY OF SCREENINGPARTICIPANTS
I agree to adhere to the following practices to safeguard the privacy of screeningparticipants:
  • The site will consent screening participants in a private setting away from the public (if applicable);
  • The site will provide barriers or a private setting if/when screening participants are required to disrobe;
  • The site will not collect sensitive or personal information about a screening participant that is not necessary for the screening.
I will be deviating from any of these expectations.Please explain or attach a letter of explanation:
11. CONFIDENTIALITY OF SCREENINGDATA
I agree to adhere to the following practices to maintain the confidentiality of screeningdata:
  • Paper screeningrecords will be physically secured (e.g., locked filing cabinets or rooms);
  • Electronic screening records will be protected with electronic safeguards (e.g., computer passwords, access privileges, firewalls, etc.);
  • Screening participant identifying information will be protected from improper use and disclosure (e.g., coding/annonymizing practices);
  • Confidentiality statements will be required of screeningstaff;
  • Access to screeningrecords will be limited only to screeningstaff;
  • Collected information will not be used for purposes other than the screeningpurposes the participant has specifically consented to and authorized.
  • Information collected during the screening will be used exclusively for Phase I Healthy studies.
I will be deviating from any of these expectations.Please explain or attach a letter of explanation:
12. COMPENSATION OF SCREENINGPARTICIPANTS
Will participants be compensated for participation in this screening?
NO, participants will notbe compensated for their participation in this screening.
YES, participants will be compensated for their participation in this screening. Please attach or include the compensation schedule for participation in the screening:
13. REIMBURSEMENT OF SCREENINGPARTICIPANTS
Will reimbursement for costs incurred, gift(s), or other inducement(s) be given to screening participants? (See the Quorum Handbook for more information.)
NO, participants will not be reimbursed for costs or provided gifts, etc. for their participation in this screening.
YES, participants may receive reimbursement for costs incurred, not including the compensation identified in question 10.Please attach or include the reimbursement schedule for costs incurred:
14. CONSENT FORM PROCESS
a.Will you be screening non-English speaking participants?
NO
YES. The languages/dialects are:
b. I agree to adhere to the following principles regarding the informed consent process for screening participants:
  • Informed consent will be obtained prior to the initiation of any screening procedures performed with the purpose of determining eligibility for research;
  • The informed consent process with potential screening participants will be conducted by the Principal Investigator, Sub-Investigator, Research Coordinator, or other authorized screeningpersonnel;
  • Potential screening participants will be allowed enough time to consider whether to consent, including taking the generic screening consent form home;
  • The person conducting the consenting process will spend as much time as is necessary to thoroughly explain and respond to the screening participant’s questions about the screening procedures;
  • An assessment will be made of screening participant understanding;
  • The generic screening consent form will be signed and dated by the screening participant and the research staff member obtaining consent;
  • A copy of the signed and dated generic screening consent formwill be provided to the screening participant to take home;
  • Any additional state/provincial-law requirements related to consent will be followed.
For more information about Quorum’s expectations about consent see Quorum’s Investigator Handbook.
I will be deviating from any of these expectations.Please explain or attach a letter of explanation:

15. TRANSLATIONS(Only applicable if non-English speaking participants will be screened.)

a.Would you like Quorum to arrange for the translation of the generic screening consent form?
NO(Skip to question 16)
YES, please translate into the following language(s):
b. Would you like Quorum to provide you a quote prior to beginning translation of the generic screening consent form?
NO
YES

16. HIPAA

a. Is the site a HIPAA-covered entity?
NO(Skip to question 17)
YES
b. Would you like Quorum to include HIPAA language in the generic screening consent form?
NO
YES
17. VULNERABLE POPULATIONS
If you plan to screen participants from vulnerable populations, please check all the applicable populations below and review the corresponding safeguards.
Vulnerable Population / Expected Safeguards and Required Attachments
Adult participants who are unable to read (e.g., unable to read due to illiteracy or physical limitations such as blindness, etc.) /
  • I will ensurean impartial witness (not affiliated with the screening) is present during the consent process to attest to the accuracy of the presentation and the apparent understanding of the participant.
  • I will enroll adult participants who are unable to readonlyif it is indicated as allowed in the approval documents issued by Quorum Review.
  • Quorum Review will add a signature blocks to the consent form for execution by the witness.
Required Attachments:
  • Letter of explanation if any listed safeguards will not be followed.

Non-English speaking participants /
  • I will ensure that a non-family member interpreter is available to interpret the screeningconsent discussion for the screening participant.
  • I will ensure that allscreening-related materialsare provided in a language understandable to the participant.
  • I will use thetranslated screening consent form issued by Quorum Review.
Required Attachments:
  • Letter of explanation if any listed safeguards will not be followed.

Economically disadvantaged /
  • I will ensure that compensation and other enticements will be set at levels that would not induce an individual to participate in screening.
Required Attachments:
  • Letter of explanation if any listed safeguards will not be followed.

Physically handicapped /
  • I will provide appropriate accommodations to physically handicapped screeningparticipants (e.g., wheelchair access).
Required Attachments:
  • Letter of explanation if any listed safeguards will not be followed.

Any other vulnerable population
Describe the population: / Describe the safeguards that will be taken:
Screening of the following vulnerable populations for Phase I Healthy Participant studies is typically not permissible:
  • Employees;
  • Children and minors;
  • Pregnant women;
  • Adults with diminished decision-making capacity to provide consentrequiring a Legally Authorized Representative.
If you intend to screen any of these populations, please specify which population you wish to include and provide rationale:
18. SIGNATURE
By signing and/or submitting this form, I am confirming that the information is accurate and all required attachments have been included in the submission. I am also confirming that I am the Principal Investigator (PI) or the PI’s designee authorized to submit on behalf of the PI and that the PI is aware of the information contained in this submission.
a.PRINCIPAL INVESTIGATOR (OR DESIGNEE) PRINTED NAME:
b.TITLE (FOR DESIGNEE):
c.PRINCIPAL INVESTIGATOR (OR DESIGNEE) SIGNATURE*: / DATE:
*A signature is not required if this form is submitted through the OnQ™ Portal. A signature is required when submitting via any other format (i.e. email, fax, hard copy mail).
SUBMISSION OPTIONS
  • Electronically: Quorum’s OnQ Portal at
  • Fax: (206) 448-4193
  • Hard Copy: Quorum Review, Inc, 1501 Fourth Ave. Ste. 800, Seattle, WA 98101

Please contact Quorum’s ClientSupport Team with any questions:

or 1-877-472-9883 Option 1

5 a.m. – 5 p.m. Pacific

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