Subject Management Activities and Costs

Subject-related activities include all those activities required to prepare, complete, document as well as complete the administrative activities for invoicing the sponsor and tracking the payments.     

Like Protocol Management, the first step is to identify all activities that will be performed during each contact with a subject.  These activities can be identified by asking questions like the following:    ​​

1. What procedures, labs, and panels will be performed at each visit?   

2. Who will provide these services?  Where will the subjects be seen?

3. What are the costs of these services?

4. What effort will the study team expend for each visit or phone contact?

5. What is the size and length of the study?

6. What is the complexity of invoicing the sponsor per the study contract? 


Answers to the above questions can be found in the following resources: 

1. Protocol

2. Informed Consent Form (ICF)

3. Draft Contract 

4. Principle Investigator (PI)

5. Sponsor Contact


Not only do these resources provide unique information, but they also – in some instances – provide the same information.  For example, the draft budget in the draft contract (i.e., the initial proposal from the sponsor in the negotiation process) should contain all of the procedures that each subject will go through.  This list of procedures in the draft contract budget must also match the procedures listed in the protocol and the ICF.  The importance of consistency between these documents cannot be overstated.  Any discrepancies should be resolved with the sponsor, prior to completing the budget negotiations, so that the final versions of these documents are in total agreement. 

The PI on the project is also a resource that can provide clarification and additional information you may need when developing a cost budget.   

While the specific language of each protocol differs, there is standardization of what information must be included.  In identifying all of the required activities for the subject-related events, the following parts (or similarly entitled parts) of the protocol often provide most of the information you need to build the subject related budget.


Protocol Introduction/Background in the Protocol/Study Summary

Understanding the context of the study can be very useful in many ways.  But certainly it helps to:

1. Interpret the specific medical labs, panels, and procedures that are referenced in the Protocol’s schedule of events. 

2. Understand more about the investigation product (drug, biologic or device) 

3. Understand the size and length of the study.


Study Objectives and Endpoints in the Protocol

As you would expect, this will provide a description of the final outcome.  The specific goal of the study.  In addition, it can also provide information about how much data will be collected at each visit, and therefore insight into how much study team effort may be reasonable.


Schedule of Events

This part of the protocol lists all labs, procedures, panels, surveys, and questionnaires that will be performed at each subject visit/contact.    This schedule is at a summary level.  Additional detail is often needed to fully understand what is planned to happen at each subject contact.  This additional detail is often found in the Treatment Plan/Study Plan and the ICF.


Treatment Plan/Study Plan

These sections of the protocol will provide additional detail of the Schedule of Events.  This additional information will help to understand if the CPT codes that are identified in the Medicare Coverage Analysis (MCA) seem reasonable.  In addition, it will help provide data that can be used to determine if the effort of the study team, and/or PI seems reasonable.   

Remember to cross reference the data in the Protocol, ICF, draft contract budget to ensure that events that will be completed at each visit is consistent.   

The above data is what the calendar builders will use in the development of the OnCore Calendar, and the coverage analysts use in the development of the Medicare Coverage Analysis (MCA), and therefore the basis for compiling the cost budget.