Case Report Forms definition

Case Report Forms means a record of the data and other information gathered on each Clinical Trial Subject pursuant to the Protocol.
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Case Report Forms or “CRFs”: shall mean the Case Report Form which is a printed, optical or electronic document designed to record all of the Study required information which shall be reported to HUMANITAS on each patient (Study Subject).
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Case Report Forms means the Case Report Forms developed and/or approved by SEARLE which are to be used by the Investigators (as hereinafter defined) to record data from the Study (as hereinafter defined).
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Examples of Case Report Forms in a sentence

  • Case Report Forms and the electronic database shall be the exclusive property of Sponsor.

  • The Principal Investigator at each institution or site will be responsible for assuring that all the required data will be collected and entered onto the Case Report Forms.

  • To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have implemented and maintain appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements.

  • Study documentation includes all Case Report Forms, data correction forms or queries, source documents, Sponsor-Investigator correspondence, monitoring logs/letters, and regulatory documents (e.g., protocol and amendments, IRB correspondence and approval, signed patient consent forms).

  • The Institution and the Investigator shall maintain accurate, complete and current records of all Study Data, including the Case Report Forms (or equivalent electronic data), relevant source documents and any other essential documents or materials as required by the Protocol, the Applicable Regulatory Requirements and PSI’s and the Sponsor’s instructions (collectively the "Records").

  • If a Study Participant discontinues their participation in the Study or if the Study is terminated as a whole, only those costs incurred up until the date of discontinuation or termination, including costs of final visit and completion of all Case Report Forms, will be paid.

  • The Investigator must certify that the data entered into the Electronic Case Report Forms are complete and accurate.

  • Study specific Case Report Forms (CRFs) will document safety and treatment outcomes for safety monitoring and data analysis.

  • Designated investigator staff will enter the data required by the protocol into the Electronic Case Report Forms using fully validated software that conforms to 21 CFR Part 11 requirements.

  • The Investigator must certify that the data entered into the electronic Case Report Forms are complete and accurate.


More Definitions of Case Report Forms

Case Report Forms means the Case Report Forms developed and/or approved by SEARXX xxxch are to be used by the Investigators (as hereinafter defined) to record data from the Study (as hereinafter defined).
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Related to Case Report Forms

  • Case Report Form means a printed, optical or electronic document or database designed to record all of the information, which is required by the Protocol to be reported to the Sponsor on each Study Participant.

  • Progress Report Form means UN Women’s standard form for progress reports attached to this Agreement.

  • Progress Report means the report similar in form and content to that attached hereto as Appendix III.

  • Assessment Report : means the assessment report referred to in Articles 32(2) and 33(3) of Regulation (EC) No 834/2007 drawn up by an independent third party fulfilling the requirements of ISO Standard 17011 or by a relevant competent authority, which includes information on document reviews, including the descriptions referred to in Articles 4(3)(b) and 11(3)(b) of this Regulation, on office audits, including critical locations and on risk-oriented witness audits conducted in representative third countries.

  • Insider Report means a statement required to be filed pursuant to Section 16 of the Exchange Act (or any successor provisions), by a person who is a director of the Corporation or who is directly or indirectly the beneficial owner of more than ten percent of the shares of the Corporation.

  • Progress Assessment Report (PAR means the monthly compliance report to Owner verifying compliance with the HUB subcontracting plan (HSP).

  • MERS Report The report from the MERS System listing MERS Designated Mortgage Loans and other information.

  • Progress Reports The Progress Reports as required by the individual Task Work Orders issued pursuant to this Agreement. Responsible: Responsible or Responsibility means the financial ability, legal capacity, integrity and past performance of Contractor and as such terms have been interpreted relative to public procurements. See NYS Finance Law § 163(1)(c).

  • Auditor’s Report means the auditor’s report on the Financial Report; “AEDT” means Australian Eastern Daylight Standard Time.