ELEMENT III.2.A.

ELEMENT III.2.A.: Researchers and research staff are qualified by training and experience for their research roles, including knowledge of applicable laws, regulations, codes, and guidance; relevant professional standards; and the organization’s policies and procedures regarding the protection of research participants.

Researchers and research staff should be qualified by training and experience for their roles and responsibilities in conducting research so that they follow the protocol and abide by the organization’s policies and procedures. Researchers and research staff should have the knowledge to follow laws, regulations, codes, and guidance such as those concerning IRB or EC review, consent requirements, reporting requirements, maintenance of records, retention of records, and supervision of research conduct. When appropriate, Researchers and research staff should understand and apply relevant professional standards that are applicable to their research.

Regulatory and guidance references

DHHS: 45 CFR 46.102(d), 45 CFR 46.102 (f)
DOJ: 28 CFR 512.11 (a)(6)
FDA: 21 CFR 50.3(a), 21 CFR 50.3(c), 21 CFR 50.3(g), 21 CFR 50.3(j), 21 CFR 56.102(c), 21 CFR 56.102(l)
ICH-GCP(E6)(R2): 2.7, 2.8, 4.1, 4.3, 4.4, 4.5, 4.6, 4.7, 4.9.1
ICH-GCP(E6)(R3): II.1.5., II.5, III.1.2., III.2.3., III.2.5, III.2.7., III.2.12.
VA: 38 CFR 16.102(d), 38 CFR 16.102 (f)
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)

Required written materials

Essential requirements:
1. Policies and procedures pertaining to Element I.1.D. that address essential requirements. If the same policies and procedures are provided to researchers and research staff, simply reference those documents in the application for this Element. If there are additional materials, such as an Investigator Handbook or Web pages for researchers, that are not included in the materials used to support Element I.1.D, but are in support of Element III.2.A., include them here.
When following ICH-GCP(E6)(R2) guideline:
1. Policies and procedures describe that:
  1. The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/EC, and/or the regulatory authority(ies).
  2. The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.
When following ICH-GCP(E6)(R3) guideline:
1. Policies and procedures describe that:
  1. The investigator(s) should be qualified by education, training and experience to assume responsibility for the proper conduct of the trial and should provide evidence of such qualifications.
  2. The investigator retains the ultimate responsibility and should maintain appropriate oversight of the persons or parties undertaking the activities delegated to ensure the rights, safety and well-being of the trial participants and the reliability of data. The level of investigator oversight of the delegated activities should depend on the nature of the delegated activities and be proportionate to the importance of the data being collected and the risks to trial participant safety and data reliability.
When following ICH-GCP(E6)(R2) or ICH(E6)(R3) guidelines:
1. The researcher provides evidence of his or her qualifications through up-to-date curriculum vitae or other relevant documentation requested by the sponsor, the IRB or EC, or the regulatory authority.
2. A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions.
3. During and following a participant’s participation in a clinical trial, the investigator ensures that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the clinical trial.
4. The researcher ensures the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor.

Common types of materials that may be used to meet the element

Researcher manual

Outcomes

Researchers and research staff are qualified by training and experience for their roles and responsibilities in conducting research.
Researchers and research staff know which laws, regulations, codes, and guidance govern their research studies and are knowledgeable about requirements pertaining to specific research studies.
Researchers and research staff are knowledgeable about the organization’s policies and procedures.

Proceed To: ELEMENT III.2.B.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT III.2.A.