Stakeholder responsibilities for documentation

The email that clarified nothing

On a Thursday afternoon in late September, Priya Sharma, a clinical research coordinator at Lakewood Regional Medical Center in Minneapolis, received an email that would consume the rest of her week.

The sponsor's clinical trial manager had written: "During our internal audit, we identified that the signed financial disclosure forms for Dr. Andersen and Dr. Kowalski are not in the eTMF. Please upload these documents by Friday EOB."

The email that clarified nothing

On a Thursday afternoon in late September, Priya Sharma, a clinical research coordinator at Lakewood Regional Medical Center in Minneapolis, received an email that would consume the rest of her week.

The email that clarified nothing

On a Thursday afternoon in late September, Priya Sharma, a clinical research coordinator at Lakewood Regional Medical Center in Minneapolis, received an email that would consume the rest of her week.

The email that clarified nothing

On a Thursday afternoon in late September, Priya Sharma, a clinical research coordinator at Lakewood Regional Medical Center in Minneapolis, received an email that would consume the rest of her week.

What you will learn

By the end of this lesson, you will be able to:

Identify the distinct documentation responsibilities of sponsors, CROs, investigators, institutions, and IRBs/IECs as defined by ICH E6(R3) and FDA regulations
Explain which sponsor responsibilities can be delegated to CROs and which cannot be transferred regardless of contractual arrangements
Describe the investigator's Form FDA 1572 obligations and their implications for documentation practices
Distinguish between the sponsor Trial Master File and the investigator site file, including what documents must appear in each
Apply the principle that delegation transfers tasks but never absolves accountability
Recognize scenarios where documentation responsibility is unclear and implement strategies to resolve ambiguity

Before we proceed, consider this question: If a document exists but is not filed in the correct location, does it fulfill its regulatory purpose? The answer, as we shall see, is often no.

What you will learn

By the end of this lesson, you will be able to:

Identify the distinct documentation responsibilities of sponsors, CROs, investigators, institutions, and IRBs/IECs as defined by ICH E6(R3) and FDA regulations
Explain which sponsor responsibilities can be delegated to CROs and which cannot be transferred regardless of contractual arrangements
Describe the investigator's Form FDA 1572 obligations and their implications for documentation practices
Distinguish between the sponsor Trial Master File and the investigator site file, including what documents must appear in each
Apply the principle that delegation transfers tasks but never absolves accountability
Recognize scenarios where documentation responsibility is unclear and implement strategies to resolve ambiguity

Before we proceed, consider this question: If a document exists but is not filed in the correct location, does it fulfill its regulatory purpose? The answer, as we shall see, is often no.

The email that clarified nothing

Stakeholder responsibilities for documentation

The email that clarified nothing

Stakeholder responsibilities for documentation

The email that clarified nothing

Stakeholder responsibilities for documentation

The email that clarified nothing

What you will learn

Continue reading this lesson

What you will learn

Continue reading this lesson