Delegation, Training Records and Qualifications

Part of Human Subjects Protection for Clinical Research Staff: Doing It Right at Your Site.

About 4 minutes. Free, in your language, no account needed.

Why this matters

On a busy study day, the investigator cannot do everything. Coordinators screen, nurses draw blood, assistants enter data. That is normal and expected. What makes it safe is that the right person is doing each task, that the investigator knows and has approved it, and that there is a record showing both.

ICH E6(R3) is the international baseline in this course. The US federal regulations (45 CFR 46, 21 CFR 50 and 56) are taught as the detailed worked example, and passages that name them are US law. Outside the United States, follow your national law and ethics committee requirements. State or local rules may add requirements, and your institution, sponsor and IRB may have their own procedures.

Delegation is allowed, responsibility is not delegated

The investigator may delegate trial-related activities to others, but the investigator retains ultimate responsibility and must maintain appropriate oversight of the trial (ICH E6(R3) sections 2.3.1 to 2.3.3). Delegation records are kept in proportion to the significance of the activities. The investigator makes sure delegates are qualified and informed.

Many sites keep this as a delegation log, a list of who may do what. Two habits make it work. Update it before someone starts a new task, not after. And do not do a task you are not listed for, even if you know how.

Qualified and trained for the task

ICH E6(R3) Principle 5.1 says that individuals involved in a trial should be qualified by education, training and experience for their tasks. Delegates are qualified and trained to match what they need for the delegated activities, beyond their usual training and experience. In other words, general experience does not by itself cover a study-specific task.

For investigators, ICH E6(R3) says they should be qualified by education, training and experience and provide evidence of that (section 2.1.1). The site needs sufficient time, qualified staff and facilities (section 2.2.2).

Training records are how a site shows these points. They record who was trained on what, and when. Which training your site needs is set by your protocol, sponsor, IRB and institution. This course does not tell you that any particular training meets any requirement.

Who may run the consent process

The informed consent process may be conducted by the investigator or by other investigator site staff delegated by the investigator, in accordance with applicable regulatory requirements (ICH E6(R3) section 2.8.5). So consent conversations are a delegated task. Being on the team is not enough. You need to be delegated, trained for the consent process in this study, and permitted by the applicable rules.

Because "applicable regulatory requirements" can differ by place, ask your investigator or IRB office what applies to your site before you take on the consent role.

What to check before you start a task

A short habit helps. Ask yourself three questions:

• Am I listed on the delegation record for this task?
• Have I been trained on this study's version of the procedure?
• Has the investigator reviewed that I am qualified to do it?

If the answer to any is no, tell the investigator before you do the task.

In practice

A new research assistant joins a site in week three of enrollment. The coordinator wants to hand over consent visits right away. Instead the coordinator asks the investigator to review the assistant's background, schedules protocol-specific training, and updates the delegation record. The assistant shadows two consent conversations first. Only after the investigator signs the updated record does the assistant lead a consent visit. The training record shows the dates and topics.

What this looks like when it goes wrong

A nurse who has done a hundred blood draws on other studies covers a Saturday visit. The study requires a specific processing step, and the nurse is not on the delegation record or trained on it. The sample is mishandled. At the next monitoring visit the monitor finds a task done by someone not delegated for it, with no training record. The investigator now has to explain how the site supervised the work. The nurse was competent in general. The failing was that the study-specific delegation and training had not been done, so the oversight the investigator is responsible for had nothing to stand on.

Key takeaways

• Investigators may delegate trial-related activities but keep ultimate responsibility and must oversee them.
• Delegation records are kept in proportion to the significance of the activities, and delegates must be qualified and trained for what they do.
• Individuals involved in a trial should be qualified by education, training and experience for their tasks.
• Consent may be conducted by the investigator or by site staff the investigator has delegated, in accordance with applicable regulatory requirements.
• Your protocol, sponsor, IRB and institution set which training is needed. This course makes no claim that any particular training meets any requirement.