Investigator Responsibilities. The Relying Institution will ensure its Investigators are aware of all of their responsibilities in the conduct of human subjects research including, but not limited to the following: Investigator is responsible for complying with the determinations and requirements of the Designated IRB. Investigator is responsible for record keeping and reporting, and for providing information requested by the Designated IRB, should there be any, in a timely manner. Investigator agrees to disclose to both the Designated IRB and the Relying Institution any changes in financial conflicts of interest and to abide by the applicable Conflict of Interest Management Plan, including additional restrictions as determined by the Designated IRB, if applicable. Investigator agrees not to implement any changes to the Research (including any applicable informed consent forms) without prior approval from the Designated IRB, except where necessary to eliminate an immediate risk of harm to participants. Any such change and the perceived risk shall be promptly reported to the Designated IRB and the Relying Institution. Investigator agrees to maintain human subjects protection education in accordance with the Relying Institution’s policies and procedures. Investigator agrees to report unanticipated problems to the Designated IRB promptly, in accordance with the Designated IRB’s policies.
Investigator Responsibilities. As the Investigator named in Part 1A above I:
Investigator Responsibilities. The Investigator is responsible for ensuring that this investigation is conducted according to all signed agreements, the study protocol, and the applicable code of Federal Regulations. This section describes these responsibilities at his/her site.
Investigator Responsibilities. X. Xxxx State Xxxxxxx investigators are responsible for: (1) disclosing the nature of the confidential data they collect so the IRB can assess the data security risk in the protocol and the research data plan supplement submitted with the IRB application; (2) preparing study data security and integrity plans and procedures in accordance with the appropriate security category requirements; and (3) contacting the ORA or the Office of OTD to establish the data transfer agreement if the data are shared with a third party. For all research involving human research data, a data security and integrity plan must be submitted to the IRB as part of the initial IRB application.
B. Upon confirmation by the IRB of the appropriate security level(s), Penn State Hershey investigators are responsible for implementing and monitoring the data security and integrity plans over the course of their projects. If human research data are stored electronically, investigators are responsible for ensuring that computers and other devices that are used to store human research information are set up correctly and operated in a manner that meets the requirements of that level. Researchers may consult with Information Technology (IT) to help them understand and meet the requirements.
X. Xxxx State Xxxxxxx investigators are responsible for ensuring that all external investigators involved in the research study with access to any human research data have signed a confidentiality agreement which is available in policy C-01 HAM and a data transfer agreement. Note: Penn State College of Medicine and Penn State Hershey Medical Center staff, faculty and students have a signed confidentiality agreement on file in their applicable Human Resource department.
X. Xxxx State Xxxxxxx investigators are responsible for ensuring that all research team members with access to human research data have completed training in the protection of human research subjects according to the IRB educational policy.
X. Xxxx State Xxxxxxx investigators are responsible for reporting breaches in confidentiality of research data (such as loss of or inappropriate access to Level 2 human research data) promptly to the IRB according to the IRB standard operating procedures for reportable new information. In addition, investigators must report incidents involving identifiable health information to the Penn State Hershey Privacy Officer at (000) 000-0000.
X. Xxxx State Xxxxxxx investigators are responsible for contacting ORA or...
Investigator Responsibilities. The investigator is responsible for ensuring that the clinical study is performed in accordance with the protocol, current ICH guidelines on Good Clinical Practice (GCP), and applicable regulatory requirements. GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting studies that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of study subjects are protected, consistent with the principles that originated in the Declaration of Helsinki and that the clinical study data are credible.
Investigator Responsibilities. All records related to the study (ie, source data, source documents, CRFs [see section 3.9], copies of protocols and protocol amendments, drug accountability forms, correspondence, patient identification lists, signed informed consent forms, and other essential documents) must be retained until ImmuPharma notifies the institution, in writing, that records may be destroyed. If ImmuPharma has not provided written notification of records destruction after 10 years from study completion (or earlier in the case of an institution closing), and the institution determines the study record retention is unduly burdensome, the institution may submit a written request to ImmuPharma at least 60 days before the planned disposition of the study records. No study document or image (eg, scan, radiograph, ECG tracing) should be destroyed without prior written agreement between the sponsor and each investigator. Should an investigator wish to assign the study records to another party or move them to another location, advance written notice will be given to the sponsor.
