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.

  • Interest shall be calculated on the outstanding principal balance of this Note and shall be payable in arrears; provided that, in the event of any change in the Prime Rate occurring on or after the date when the Payee mails an invoice for the monthly payment amount to the Maker, any such change in the interest payment shall be reflected as an adjustment in the next monthly invoice sent to the Maker and shall not be deemed to be due and payable until that date.

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

  • 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.

  • 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.

  • Flaring away to the edge of the clear zone (For Work Zone Clear zones, see theDesign Standards, Index 600) 10.11.4 Modifications of Existing Barriers‌ When 2-way traffic is placed on a facility that is normally one-way, the existing permanent or temporary barriers will be modified as necessary to ensure their proper crashworthiness during the temporary situation.

  • Following a determination to apply Ceded Review pursuant to Section 3.2, the Participating Institution of the Overall PI will have the opportunity to decide whether it will serve as the Reviewing IRB Institution for the Research (if the Participating Institution has an IRB), unless another Reviewing IRB is required or designated pursuant to applicable regulation, funding policy, or other external requirements.

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 is able to operate in cogeneration mode;

  • 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 the entire operation located on the property where the Equipment is located;

  • 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.

  • Commercial Operator means the person appointed by MDL as commercial operator of the Maui Pipeline from time to time.

  • 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 property including the land, improvements, indoor air, groundwater, and surface water that is or at any time has been owned, operated, occupied, controlled or leased by the Company, its Subsidiaries or any of their predecessors in connection with the operation of their respective 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. Generation Interconnection Customer:

  • 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 Request:

  • 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 36.2.

  • 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).

  • 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 :

  • Clean coal SNG facility means a facility that uses a