Investigator Records Sample Clauses

Investigator Records. ‌ Each Investigator must maintain the following accurate, complete, and current records relating to the conduct of the investigation. The data for some of these reports may be available in computerized form from the sponsor but the final responsibility for maintenance remains with the Investigator. Study-related documents must be retained for a minimum of two years after study completion and access must be permitted to the study sponsor monitor to inspect facilities and records. Specific examples of records maintenance include:
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Investigator Records. Prior to participation in the investigation, the investigator must provide the following documentation to the Sponsor: • Investigator Agreement, signed by the investigator, which lists any physicians who will be involved in conducting the investigation under the direction of the primary investigator; • A copy of the principal investigator’s, sub-investigator’s, other delegated study clinicians’ curriculum vitae; • A letter signed by the chairperson of the IRB or EC overseeing the conduct of this study indicating that the IRB or EC has reviewed and approved this investigational plan; and • A copy of the IRB- or EC-approved Informed Consent Form. During the study, investigators are required to maintain on file the following accurate, complete, and current records relating to this study as described in 21 CFR §812.140. A summary of these records is listed below: • All correspondence and required reports, which pertain to the study. • Records of receipt, use, or disposition of study devices, including the type and quantity of devices; the dates of receipt; the serial numbers; the names of all persons who received, used or disposed of each device; and why and how many units of the device have been returned to the Sponsor, repaired, or otherwise disposed. • Records of each subject’s case history and exposure to the device. • Signed and dated consent forms. • Relevant observations, including records concerning adverse events, condition of each subject upon entering and results of diagnostic tests. • Study-specific data forms and corrections to the forms. • Protocol and amendments. • Subject recruiting materials. • Investigator curriculum vitae.
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Related to Investigator Records

  • Contractor Records A. Maintenance Contractor shall maintain a file of all documents, records, communications, notes and other materials relating to the Work (the “Contractor Records”) performed by the Contractor and any Subcontractors, that are required to ensure proper performance of that Work. Contractor shall maintain Contractor Records until the last to occur of: (i) the date 3 years after the date this Participating Addendum expires or is terminated, (ii) final payment under this Participating Addendum is made, (iii) the resolution of any pending Contract matters, or (iv) if an audit is occurring, or Contractor has received notice that an audit is pending, the date such audit is completed and its findings have been resolved (the “Record Retention Period”).

  • Investigator Where a difference arises between the parties relating to the dismissal, discipline or suspension of an employee, or to the interpretation, application, operation or alleged violation of this agreement, including any questions as to whether a matter is arbitrable, during the term of the collective agreement, an arbitrator agreed to by the parties shall, at the request of either party:

  • Grievance Records All documents, communications, and records dealing with the processing of a grievance shall be filed separately from the personnel files of the participants.

  • Complaints Investigation ‌ An employee who complains of harassment under the provisions of the Human Rights Code of British Columbia may refer the complaint to either one or other of the following processes:

  • Investigatory Interview When the employee under investigation is to be interviewed concerning the alleged conduct which could result in discharge or other discipline, the employee and his or her representative shall be notified in writing, at least forty-eight (48) hours prior to the interview. In the event of an emergency, such reasonable notice as the circumstances permit shall be given. The notice shall state that an official investigation is being conducted and shall state the subject matter of the investigatory interview.

  • Grievance Investigations Where an employee has asked or is obliged to be represented by the Institute in relation to the presentation of a grievance and an employee acting on behalf of the Institute wishes to discuss the grievance with that employee, the employee and the representative of the employee will, where operational requirements permit, be given reasonable leave with pay for this purpose when the discussion takes place in the headquarters area of such employee and leave without pay when it takes place outside the headquarters area of such employee.

  • Customer Records Customer grants to Cisco and its independent accountants the right to examine Xxxxxxxx's books, records and accounts during Customer's normal business hours to verify compliance with this Agreement. In the event such audit discloses non-compliance with this Agreement, Customer shall promptly pay to Cisco the appropriate license fees, plus the reasonable cost of conducting the audit.

  • Educational Records Educational Records are official records, files and data directly related to a student and maintained by the school or local education agency, including but not limited to, records encompassing all the material kept in the student’s cumulative folder, such as general identifying data, records of attendance and of academic work completed, records of achievement, and results of evaluative tests, health data, disciplinary status, test protocols and individualized education programs. For purposes of this DPA, Educational Records are referred to as Student Data. NIST: Draft National Institute of Standards and Technology (“NIST”) Special Publication Digital Authentication Guideline.

  • PROFESSIONAL RECORDS You should be aware that, according to the rules of HIPAA, I keep Protected Health Information about you in two sets of professional records. One set constitutes your Clinical Record. It includes information about your reasons for seeking therapy, a description of the ways in which your problem impacts on your life, your diagnosis, the goals that we set for treatment, your progress towards those goals, your medical and social history, your treatment history, any past treatment records that I receive from other providers, reports of any professional consultations, your billing records, and any reports that have been sent to anyone, including reports to your insurance carrier. In addition, I also keep a set of Psychotherapy Notes. These Notes are for my own use and are designed to assist me in providing you with the best treatment, While the content of Psychotherapy Notes vary from client to client, they can include notes regarding the contents of our conversations, my analysis of those conversations, and how they impact on your therapy. They also can contain particularly sensitive information that you may reveal to me that is not required to be included in your Clinical Record. These Psychotherapy Notes are kept separate from your Clinical Record. While insurance companies can request and receive a copy of your Clinical Record, they cannot receive a copy of your Psychotherapy Notes without your signed, written Authorization. Insurance companies cannot require your Authorization as a condition of coverage nor penalize you in any way for your refusal. You may examine and/or receive a copy of both sets of records, if you request it in writing. Because these are professional records, they can be misinterpreted and/or upsetting to untrained readers. For this reason, I recommend that you initially review them in my presence, or have them forwarded to another mental health professional so you can discuss the contents. In most circumstances, I am allowed to charge a fee for copying records. The exceptions to this policy are contained in the Privacy Notice form. PATIENT RIGHTS HIPAA provides you with several new or expanded rights with regard to your Clinical Record and disclosures of protected health information. These rights include requesting that I amend your record; requesting restrictions on what information from your Clinical Record is disclosed to others; requesting an accounting of most disclosures of Protected Health Information that you have neither consented to nor authorized; determining the location to which protected information disclosures are sent; having any complaints you make about my policies and procedures recorded in your records; and the right to a paper copy of this Agreement, the Privacy Notice form, and my privacy policies and procedures. I am happy to discuss any of these rights and/or issues with you. MINORS & PARENTS Patients under 18 years of age who are not emancipated and their parents should be aware that the law may allow parents to examine their child’s treatment records. Because privacy in psychotherapy is often crucial to successful progress, particularly with teenagers, it is sometimes my policy to request an agreement from parents that they consent to give up their access to their child’s records. If they agree, during treatment, I will typically provide them only with general information about the progress of the child’s treatment, and his/her attendance at scheduled sessions. I also may provide parents with a summary of their child’s treatment when it is complete. Most other communication will require the child’s Authorization, unless I feel that the child is in danger or is a danger to someone else, in which case, I will notify the parents of my concern. Before giving parents information, I will discuss the matter with the child, if possible, and do my best to handle any objections he/she may have.

  • Grievance Investigation The Employer agrees to supply to the Union the names of all applicants for a vacancy, or new position in the course of a grievance investigation.

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