Nursing Staff Research Feasibility Screening

Section 1

1.1 Will staff nurses perform only routine clinical care, with no tasks specified in the study protocol?

YesNoUnsure

1.2 Will the study team request the staff nurses to perform any tasks, either within or outside their normal workflow?

YesNoUnsure

Do not consider only routine clinical care; include all tasks initiated by the study protocol or schedule of activities.

Section 2

Instructions:
Describe nursing activities exactly as they occur in the study protocol. Relevant information may be found in the Schedule of Activities as well as other sections of the protocol (e.g., procedures, intervention details, or safety monitoring). Include timing and frequency where specified.

List each study timepoint where staff nurses are involved. For each timepoint, list each nursing task separately and specify when and how often it occurs.

Do not summarize. Do not write “per protocol.” Provide exact timing and details as written in the protocol.

For each study timepoint involving staff nurses, please repeat section 2.1 - section 2.3.

2.1 Study Timepoint / Visit Name

(e.g., Screening, Day 1 Procedure, Post-Procedure Monitoring, Weekly Treatment Visit)

Section 3: Medication/ Intervention Administration

3.1 Will staff nurses administer investigational medications or devices?

YesNoUnsure

If YES, describe monitoring requirements (include timing):

Section 4: Specimen Collection

4.1 Will staff nurses collect specimens?

YesNoUnsure

Type of specimens

BloodUrineOther

If selected "Other", please provide a brief description:

Are collections required at specific timepoints?

YesNoUnsure

If selected "Yes", list all timepoints or visit name

Section 5: Data Collection & Documentation

5.1 Will staff nurses be responsible for study-related documentation or data collection (including adverse event documentation)?

YesNoUnsure

Select all that apply

Completing case report forms (CRFs)Logging nursing observations for the studyEntering data in the EHR for study purposesFollowing study-specific documentation requirementsOther

If selected "Other", provide a brief task description:

Describe documentation requirements

Section 6: Training & Educational Materials

6.1 Does the study require training or provide educational materials for staff nurses?

YesNoUnsure

Provide a brief description of the training content

Please upload the study protocol:

Please upload the educational materials

e.g., guidelines, protocols, escalation pathways

6.2 Are nurses required to follow study-specific escalation protocols?

YesNoUnsure

Please provide a brief description:

Section 7: Operational Responsibility

7.1 Who is responsible for ensuring study-related tasks are completed?

Study teamUnit nursing staffShared responsibilityUnsure

7.2 Study team contact for nursing coordination:

Provide name and email