Budgets for Clinical Trial Sites

November 14, 2018

 

Greetings everybody

 

Just a few weeks ago, we hosted some very interesting and interactive sessions at the SACRA Clinical Trial Conference.

As expected, site budgets and issues regarding payment had come up on a few occasions. This is an issue that repeatedly needs addressing, and given the increasing complexity of clinical trial protocols, it is becoming more critical as the months tick by.

I promised one of my colleagues that I will post the budget items that I review at my site. The amounts have been left out deliberately, as there is some law against what appears to be collusive practice. If you choose the items in my list, you should allocate your own amounts.

 

Procedure

Informed consent

Inclusion/exclusion criteria

Demographics and medical history

Height / Weight / BMI

Vital signs

Physical examination

Rapid antigen test

Pregnancy test (urine)

12-lead ECG

Spirometry (single)

Spirometry (pre and post)

Laboratory tests (phlebotomy)

Laboratory sample shipping and handling

Laboratory result assessment

Virologic test (swabs)

Adverse event assessment

Conmed Assessment

IP dispensing

IP accountability and temp monitoring

Diary training

Diary review

Questionnaire (short)

Questionnaire (long)

Wound measurements

Fundoscopy

Photography

SIRS scale

Diet or other counselling

HIV pre-test and post-test counselling

Chest X-ray

Nitric oxide measurement

Pulse oximetry

Urinalysis

SAE reporting

Telephone contact

IV Line insertion

IV drug preparation and infusion monitoring

 

Non-procedure

Data entry

Study coordinator fee

Study coordinator fee (short)

Physician fee

Physician fee (short)

Pharmacist fee

Subject allowance (normal)

Subject allowance (extended)

Site setup fee

Archiving fee

 

Overhead fee

15%

 

The above list obviously looks at specific line items that should be outlined in a CTA.

There are other issues to consider as well. These include:

  1. Payment terms – I find no justification for a quarterly payment cycle, as we usually have a few days to enter data in EDC systems. Being a data driven industry, payment terms should be a minimum of a monthly payment cycle.

  2. Start-up fees – my research has shown that approximately 60 hours are spent in start-up activities. These should be acknowledged by sponsors, and reimbursed to sites.

  3. Reconsenting fees – Again, based on time involved for the many possible amendments in a study

  4. Screen failure caps – this is a significant problem in some studies. I have declined studies if the sponsor had not considered relaxing this part of the CTA

  5. Archiving fees – this should be based on actual costs – it is not possible to predict at the start of the study how many boxes will be needed

 

These are the basics that I look for in my CTA review. I am certain that each site has there own processes of review and I will be keen to learn from you.

 

This will be my last blog post for 2018. Wishing you all a safe festive season, and the best for 2019.

 

Dr Essack Mitha

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