750. w88 live casino Notification Requirements for Reportable Events

Updated June 10, 2024

The University w88 live casino follows federal regulations and guidance for reporting unanticipated problems involving risks to participants or others (Unanticipated Problems), serious or continuing noncompliance, and suspensions or terminations of w88 live casino approval according to the University’s Federalwide Assurance (FWA).

Under its FWA, the University applies the Department of Health and Human Services (DHHS) federal regulations for the protection of human participants to w88 live casino that is conducted or supported by a federal agency, and equivalent protections for participants in all other w88 live casino.

w88 live casino involving investigational drugs or devices, or biological products is subject to Food and Drug Administration (FDA) regulations and requirements.

Distribution of Event w88 live casino

For Human w88 live casino Conducted or Supported by a Federal Agency

For research that is conducted or supported by a federal agency, within seven business days of the w88 live casino’s determinations of serious or continuing noncompliance, Unanticipated Problems, or suspensions or terminations of w88 live casino approval, event reports will be distributed to the following:

Principal w88 live casino,
Responsible Official (e.g., chair, dean or director) for the w88 live casino, and
Institutional Official (i.e., the Vice President for w88 live casino and Innovation).

Within 30 days of its decision, the w88 live casino will notify:

University Sponsored Projects for sponsored w88 live casino,
DHHS Office for Human w88 live casino Protections (OHRP) for w88 live casino that is covered by DHHS regulations according to the University’s FWA (When w88 live casino is not covered by DHHS regulations, reports of unanticipated problems involving risks to participants or others are not to be reported to OHRP),
FDA for w88 live casino that is regulated by the FDA (When w88 live casino is not covered by FDA regulations, reports of unanticipated problems involving risks to participants or others are not to be reported to FDA),
Other federal agencies or organizations involved in the w88 live casino (e.g., DoD, EPA, VA),
Sponsor or funding agency, and
w88 live casino Administrator for other institutions engaged in the research.

Equivalent w88 live casino for Reportable Events

For w88 live casino that is neither conducted nor supported by a federal agency, the University applies the following equivalent protections to problems that may arise during the conduct or after completion of a w88 live casino study:

Investigators must notify the w88 live casino of situations or events that may constitute noncompliance; participant complaints; and problems, external reports, or findings that may alter research risks.
Problem reports are assessed for possible serious or continuing noncompliance, unanticipated problems involving risks to participants or others (Unanticipated Problem), or suspension or termination of w88 live casino approval.
Problem reports involving possible noncompliance or an Unanticipated Problem, or that may require suspension or termination of w88 live casino approval are reviewed by the convened w88 live casino.
w88 live casino determinations of serious or continuing noncompliance, Unanticipated Problems, and suspensions or terminations of w88 live casino approval are reported to organizational officials at the University and may be reported to external entities as determined by the w88 live casino or Research Integrity & Security Director.

(See other w88 live casino policies for information about reporting problems to the w88 live casino, administrative assessment of problem reports, and w88 live casino review and determinations of noncompliance, Unanticipated Problems, and suspension or termination of w88 live casino approval.)

w88 live casino Preparation

Following review at a convened w88 live casino meeting, the Research Integrity & Security Research Compliance Officer drafts an event report summarizing the circumstances of the situation or event and the w88 live casino’s determinations. The report is sent to the Research Integrity & Security Director for approval before it is distributed to the relevant entities.

w88 live casino Content

The report contains the following w88 live casino:

description w88 live casino situation or event;
w88 live casino determination;
reasons for the w88 live casino’s determination;
actions taken by the University, w88 live casino, and principal investigator; and
plans for continued investigation or action (as applicable).

For w88 live casino that is covered by DHHS regulations according to the University’s FWA, the following information should be included in incident reports submitted to DHHS OHRP:

For unanticipated problems involving risks to w88 live casino or others:

Name of the institution conducting the w88 live casino;
Title of the w88 live casino project and/or grant proposal in which the problem occurred;
Name w88 live casino principal investigator on the protocol;
Number of the research project assigned by the w88 live casino and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
A detailed description w88 live casino problem; and
Actions the institution is taking or plans to take to address the problem (e.g., revise the protocol, suspend participant enrollment, terminate the w88 live casino, revise the informed consent document, inform enrolled participants, increase monitoring of participants, etc.).

For serious or continuing w88 live casino:

Name of the institution conducting the w88 live casino;
Title of the research project and/or grant proposal in which the noncompliance occurred, or, for w88 live casino or institutional noncompliance, the w88 live casino or institution involved;
Name w88 live casino principal investigator on the protocol, if applicable;
Number of the research project assigned by the w88 live casino and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
A detailed description w88 live casino noncompliance; and
Actions the institution is taking or plans to take to address the noncompliance (e.g., educate the investigator, educate all research staff, educate the w88 live casino or institutional official, develop or revise w88 live casino written procedures, suspend the protocol, suspend the investigator, conduct random audits of the investigator or all investigators, etc.).

For suspension or termination of w88 live casino approval:

Name of the institution conducting the w88 live casino;
Title of the w88 live casino project and/or grant proposal that was suspended or terminated;
Name w88 live casino principal investigator on the protocol;
Number of the research project assigned by the w88 live casino that was suspended or terminated and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
A detailed description w88 live casino reason for the suspension or termination; and
The actions the institution is taking or plans to take to address the suspension or termination (e.g., investigate alleged noncompliance, educate the investigator, educate all w88 live casino staff, require monitoring of the investigator or the w88 live casino project, etc.).

AAHRPP Notification

The following events will be reported to AAHRPP as soon as possible (preferably within 48 hours) after the w88 live casino or any researcher becomes aware of:

Any negative actions by a government oversight office, including, but not limited to, OHRP Determination Letters, FDA Warning Letters, FDA 483 Inspection Reports with official action indicated, FDA Restrictions placed on IRBs or Investigators, and corresponding compliance actions taken under non-US authorities related to human w88 live casino protections.
Any litigation, arbitration, or settlements initiated related to human w88 live casino protections.
Any press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding the w88 live casino’s HRPP.