What is a Sub-Study?

A sub-study asks a separate research question from the parent protocol, contributes to the parent protocol’s objectives and uses all or a subset of study participants or specimens. 

The sub-study may be incorporated into a main/parent protocol OR a separate sub-study protocol may be created and submitted under the same IRB # if the appropriate criteria are met.

 

When may the addition of a sub-study be considered a Modification or Amendment to the main/parent study?

The addition of a sub-study may be considered a modification or amendment if all of the following criteria are met:

  • Sub-study hypothesis and objectives compliments and are consistent with the aims of the main/parent study. 
    • When the data being collected in the sub-study complements the data collected in the existing parent protocol. 
    • To collect data related to that population’s experience in the study or with the investigational product (e.g. quality of life survey).
  • The subjects being enrolled in the sub-study are a subset of the subjects enrolled in the main/parent study that is being modified.
  • The funding source for the sub-study is the exactly the same (same sponsor or same grant).
  • Enrollment tracking and adverse event reporting may be done under the main/parent protocol. Separate enrollment tracking and adverse event reported are not needed at the UVA IRB Level (see below for additional information).
  • A database protocol is not being added. A separate database protocol is always required to create a data or tissue repository.

When is a new study submission required?

A separate new study is required if:

  • Study objectives or outcomes differ from the existing main/parent protocol.
  • Subjects to be enrolled in the sub-study are NOT a subset of the subjects in the main/parent protocol.
  • Funding source for the sub-study is different from the main/parent study.
  • Separate enrollment tracking and adverse event reporting are needed at the UVA IRB level. (see below for additional information).
  • Storing samples and/or data for future research (bio-bank protocol). A separate database protocol is always required for this type of situation.

Which submission is the most appropriate for this sub-study?

Submit the SUB-STUDY- Add to existing protocol as an Amendment or Modification

Submit the SUB-STUDY as a new stand-alone study 

(new IRB #/ UVA Study Tracking# is required) 

Objectives/hypothesis are consistent with the main/parent study.   They need not be identical but serve to expand the original research intent.

Objectives/Hypothesis are broadly different than the main/parent study. 

Subjects enrolled in the sub-study are a subset of those subjects enrolled in the main/parent study

Subjects enrolled in the sub-study are NOT a subset of those subjects enrolled in the main/parent protocol. 

Same funding source/or same grant as the main/parent study

Different funding source or different grant than the main/parent study

Sub-study does not requires separate tracking at the local IRB level for enrollment and/or adverse event reporting:

- Enrollment totals – will not require separate tracking with the IRB.   Enrollment in the sub-study will not be reported as separate from the enrollment in the main/parent protocol at the time of continuing review.  (e.g., enrollment numbers will be combined (numbers of those participating in the sub-study are not counted separately from the main/parent study enrollment number),

- Adverse Events will be reported under the main/parent protocol

Sub-study requires separate tracking at the local IRB level for enrollment and/or adverse event reporting: 

- Enrollment totals –require separate tracking with the IRB.   Enrollment in the sub-study will be reported as separate from the enrollment in the main/parent protocol at the time of continuing review.  (e.g., enrollment numbers will NOT be combined (numbers of those participating in the sub-study are counted separately from the main/parent study enrollment number)

- Adverse events need to be reported to the IRB-HSR separately from those of the main/parent protocol. 

A DATABASE PROTOCOL is not being added to the main/parent study.   A separate DATABASE PROTOCOL submission is always required to store data or specimens after the main/parent study closes.

A DATABASE PROTOCOL is being added to the main/parent study.   A separate DATABASE PROTOCOL submission is always required to store data or specimens after the main/parent study closes