Overall PI definition

Overall PI. The lead multi-site principal investigator with ultimate responsibility for the conduct and integrity of Research (generally, the initiating principal investigator or funding principal investigator, as applicable).
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Examples of Overall PI in a sentence

  • The Overall PI, as study sponsor, will be responsible for all communications with the FDA.

  • The Overall PI will report to the FDA, regardless of the site of occurrence, any serious adverse event that meets the FDA’s criteria for expedited reporting following the reporting requirements and timelines set by the FDA.

  • Information that raises any questions about participant safety will be addressed with the Overall PI and study team.

  • Issues that would cause treatment delays should be discussed with the Overall PI.

  • The Participating Institution of the Overall PI may also on its own initiative determine that particular Research may be appropriate for Ceded Review.

  • If the Overall PI and the Overall PI’s Participating Institution are not seeking but do not object to Ceded Review, other Participating Institutions may still participate in a Ceded Review; in that case, a Site Investigator (defined in Exhibit A) may make a request for Ceded Review of the Research to the IRB of the Participating Institution where the Site Investigator is primarily employed or affiliated.

  • Promptly notify the Overall PI, Site Investigator(s), and the Relying Institution(s) of its determinations (e.g., exemption) or review decisions regarding the Research (e.g., approval, disapproval, required modifications); of changes in the Research reviewed and approved by the Reviewing IRB after initial approval; and of lapses in IRB approval and any applicable corrective action plans.

  • Unless otherwise agreed, the Reviewing IRB(s) (or designee(s)) shall generally be the one(s) to notify the Overall PI and the Site Investigator(s) and the applicable Participating Institutions (i) whether the request for Ceded Review of the Research has been accepted or declined under this Agreement; and (ii) if accepted, which IRB(s) shall be the Reviewing IRB(s).

  • The Relying Institution will also promptly notify the Reviewing IRB/Reviewing IRB Institution of communications received by the Relying Institution or between the Relying Institution and FDA, OHRP, and/or other regulatory agencies, regarding unanticipated problems, noncompliance, or other compliance concerns regarding the Research, and will require the Overall PI and Site Investigator(s) to do the same with respect to such communications between the Overall PI or Site Investigator(s) and such agencies.

  • If the Participating Institution of the Overall PI (or of the requesting Site Investigator as provided above) determines that the Research may be appropriate for Ceded Review, that Participating Institution shall consult, as needed, with relevant Participating Institutions (or designee(s)) involved in the particular Research to determine whether each agrees that the requested Research is appropriate for Ceded Review.

Related to Overall PI

  • Facility Manager The Authorized User’s representative who is responsible for the day to day operations of the facility(s) referenced in the Project Definition.

  • Cogeneration unit means a unit that has equipment used to produce electric energy and forms of useful thermal energy (such as heat or steam) for industrial, commercial, heating or cooling purposes, through the sequential use of energy.

  • Public facility means 1 or more of the following:

  • Generating Facility means the Generating Unit(s) comprising Seller’s power plant, as more particularly described in Section 1.02 and Exhibit B, including all other materials, equipment, systems, structures, features and improvements necessary to produce electric energy and thermal energy, excluding the Site, land rights and interests in land.

  • Processing facility means an establishment that prepares, treats, or converts tangible personal property into finished goods or another form of tangible personal property. The term includes a business engaged in processing agricultural, aquacultural, or maricultural products and specifically includes meat, poultry, and any other variety of food processing operations. It does not include an establishment in which retail sales of tangible personal property are made to retail customers.

  • Wireline backhaul facility means a facility used to transport services by wire or fiber-optic cable from a wireless facility to a network.

  • Facility Operator means a person that controls the operation of a facility.

  • Facility means any real property (including all buildings, fixtures or other improvements located thereon) now, hereafter or heretofore owned, leased, operated or used by Borrower or any of its Subsidiaries or any of their respective predecessors or Affiliates.

  • Generation Interconnection Request means a request by a Generation Interconnection Customer pursuant to Tariff, Part IV, subpart A, to interconnect a generating unit with the Transmission System or to increase the capacity of a generating unit interconnected with the Transmission System in the PJM Region.

  • LNG facility means a terminal which is used for the liquefaction of natural gas or the importation, offloading, and re-gasification of LNG, and includes ancillary services and temporary storage necessary for the re-gasification process and subsequent delivery to the transmission system, but does not include any part of LNG terminals used for storage;

  • Cannabis processing facility means a person that:

  • Business Facility means any real property including the land, the improvements thereon, the groundwater thereunder and the surface water thereon, that is or at any time has been owned, operated occupied, controlled or leased by the Company or any Subsidiary in connection with the operation of its business.

  • Public facilities means amenities that are—

  • Generating Facilities means Interconnection Customer’s device for the production and/or storage for later injection of electricity identified in the Interconnection Request, but shall not include the Interconnection Customer’s Interconnection Facilities.

  • Sub-acute facility means a facility that provides intermediate care on short-term or long-term basis.

  • Dry cleaning facility means an establishment with one or more dry cleaning systems.

  • Generation Interconnection Customer means an entity that submits an Interconnection Request to interconnect a new generation facility or to increase the capacity of an existing generation facility interconnected with the Transmission System in the PJM Region.

  • Generation Interconnection Feasibility Study means a study conducted by the Transmission Provider (in coordination with the affected Transmission Owner(s)) in accordance with Tariff, Part IV, section 36.

  • Water Supply Any problem with water supply? Yes No Unknown Comments: Home water treatment system: Yes No Unknown Comments: Fire sprinkler system: Yes No Unknown Does Not Apply Comments: Are the systems in operating condition? Yes No Unknown Comments:

  • Wastewater Facilities means the structures, equipment, and processes required to collect, carry away, and treat domestic and industrial wastes and dispose of the effluent.

  • Electric Facility means a Generator or an electric transmission facility.

  • Stormwater management BMP means an excavation or embankment and related areas designed to retain stormwater runoff. A stormwater management BMP may either be normally dry (that is, a detention basin or infiltration system), retain water in a permanent pool (a retention basin), or be planted mainly with wetland vegetation (most constructed stormwater wetlands).

  • Participating Facility means, for purposes of this section only, with respect to covered service, a Hospital, Hospital outpatient department, critical access Hospital, ambulatory surgical center or any other facility as otherwise required by law, that has a direct or indirect contractual relationship with BCBSMT setting a rate (above which the provider cannot bill the Member) for furnishing such item or service under The Plan, regardless of whether the provider is considered a preferred or In-Network provider for purposes of In-Network or Out-of-Network Benefits under The Plan.

  • Facility Owner has the meaning given to the term facility owner in Section 17(6) of the Act;

  • Designated facility means (a hazardous waste treatment, storage, or disposal facility which :

  • Project Facility means facility being one or more of the following facilities as specified in the Special Conditions of Contract, being developed in accordance with the Project and the Detailed Project Implementation Report and includes all its buildings, equipment, facilities, software and systems and includes without limitation, where the circumstances so require, any expansion thereof from time to time and may include any new location to be separately mentioned in the Special Conditions of Contract.