ComplaintsforSpaulding Clinical Research, LLC

• Initial Complaint

  04/11/2023

  Complaint Type:

  Product Issues

  Status:

  Answered

  More info

  Spaulding Clinical recruits study participants for experimental lab studies. They advertised a study named ***** for a specified amount and then later increased that amount because they could not recruit enough participants. When this happens, current participants are also to receive the increase in pay. This is standard process for this industry. I screened and was asked to check in for Group 3 of the ***** study. I was selected as an alternate for that study and went home the next day. I was called and asked again to check in for ************** 4 and was enrolled in that study. I stayed at the facility the required number of days and came back for my outpatient appointment(OPV) in March. While waiting I noticed Group 3 was checking in for the 2nd portion of their study. I asked a worker if the increased stipend for the study would be added to this check. She said she was not sure. I asked to speak to a supervisor. *** came down to speak to me and another study participant from ************** 4. *** showed us a letter from the **** stating from their interpretation of the letter they were not required to pay our Group 4 the increased stipend amount. I asked to read it and it clearly stated that "all currently enrolled study participants were entitled to the increase stipend". I said it clearly states ALL CURRENTLY ENROLLED study participants. We were still enrolled, we were the ************** 4. He said in their interpretation, since we are not dosing again, it does not apply to us. For the record, I have done studies their in the past were we received the increased stipend without having to reconsent. It was automatically added to our next checks and there was no need for any dispute. Also for the record, there were only 2 participants in the ************** 4, both minorities, an African man and myself, a Hispanic woman. I sent an email but have not heard back from anyone and last week received my last check without increased payment.

  Business response

  06/26/2023

  I am writing to address your concern that was brought to my attention by your email/notice below. It is noted that *************************** had raised a concern that she did not receive the full payment for her participation in the study and indicated that she was not offered the new stipend from the updated ICF dated 16Mar2023.
  
  Upon reviewing her participation file, we have confirmed that she has received a total of $2750 per her signed consent (version 11Jan2023) which was signed on 08 Feb 2023.
  This was made in 5 payments to her as listed below.
  1. one check provided via mail on 03Mar2023 for $350 = $100 for screening and $250 for being a check in alternate,
  2. then $960 in person check on 10Mar2023 .
  3. $480 in person check on 13Mar2023.
  4. $720 in person check on 20Mar2023.
  5. $240 mailed check on 03Apr2023.
  
  We also noted that a new consent form was received to SCR for this study on 16Mar2023, which was approved by the ************************** (***). However, the *** approval letter states that "new subjects and currently enrolled subjects receiving the applicable study treatment/drug need to sign the above referenced Consent Form(s)." As she was no longer receiving study treatment at that time, she does not meet the criteria for signing the new consent form with the increased stipend. We can confirm that she was paid in accordance with the consent form that was signed on 08 Feb 2023.
  
  I can confirm the Gracielas last dosed on 07Mar2023 at 08:30:00. Below is a summary of her dose source for your reference:
  This is the first and only dose for this subjects group as she participated in Cohort 4 sentinel dose in the SAD portion of the study.
  Date/Time taken 07Mar2023 08:30:00/ was the full dose taken= Yes/ Dose Formula= capsule

  ********* had also made a complaint to the ************************** (***) and she was provided the following response from the *** Advarra:
  
  Thank you for your patience while we investigate this matter. I have reached out to the research site to get clarifying information regarding the details surrounding your payment for this study. In speaking with the site, they confirmed that at the time the new consent was issued, you were no longer receiving the study treatment that would make you applicable at the time for reconsenting and the increased stipend amount. Per the informed consent you signed, you were provided the full payment for your participation in this study. As no additional procedures were conducted other than follow up, there is no cause for further intervention from the *** at this point regarding this issue.
  
  From the information that we received from the research site, your last dose at the research facility was on March 7, 2023, which is prior to the issue date of the informed consent dated 16Mar2013. If you can provide evidence of the contrary, we are more than welcome to look into this further
  
  Recently ******** noted that she only received $2500, however per our accounts it shows the following:
  
  Vendor Name Document Type Document Date Details Document Amount Check 
  **************************** Invoice 3/2/2023 Check # ***** for $350.00 Cashed Date: 3/13/2023
  **************************** Invoice 3/9/2023 Check # ***** for $960.00 Cashed Date: 3/13/2023
  **************************** Invoice 3/10/2023 Check # ***** for $480.00 Cashed Date: 3/14/2023
  **************************** Invoice 3/19/2023 Check # ***** for $720.00 Cashed Date: 3/21/2023
  **************************** Invoice 3/31/2023 Check # ***** for $240.00 Cashed Date: 4/7/2023
  
  Total Compensation for ***** Study Participation $                         2,750.00

• Initial Complaint

  09/09/2022

  Complaint Type:

  Delivery Issues

  Status:

  Unanswered

  More info

  I enrolled in a study with this company and was provided the schedule for payouts. On august 19th 2022 I received my last follow up call which ended the study. At this time I was told my final payments would be mailed out to me on that date (august 19,2022). I still have not received my last payments and each time I call to inquire Im told different things and told to wait, no one can give me a real update or sufficient answers. Would not recommend participating in a study at this facility.

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