Dear Ms. [redacted],Thank you for contacting PPD this week to share the feedback regarding a customer’s screening experience at our Phase I Clinic on November 24. 2014. Upon further review with staff facilitating procedures that day, the recruiter informed our Subject Relations staff of the...
complaints regarding the screening outcome. We reached out to the volunteer to respond to the concerns and offer clarity to any questions. As part of the initial response steps, we determine whether or not the volunteer has been to the site before. If the volunteer is new to the clinic, additional detail is provided about what to expect during the recruiting and study conduction process. In these specific circumstances, our staff extended an apology for the frustrations and inconvenience encountered. We offered to review actively recruiting studies for potential screening options that aligned with his availability. The offer was declined. During the medical history phone interview and before an appointment is scheduled, the phone recruiter makes the following statements, “There is no compensation for the screening process. No one is assured a place in the study until the first dosing is completed.” This is also conveyed in writing if the volunteer remains qualified upon completion of the initial phone interview and elects to schedule an appointment for the on-site informed consent session often referred to as a screening appointment. During the screening appointment, the recruiter reviews the documents and includes a segment affording volunteers the opportunity to ask questions, is issued a copy of the study dates and the recruiter’s direct contact information should there be any questions after the screening appointment. Before screening procedures are performed, volunteers must read and sign the Subject Rules and Regulations and Informed Consent documents. By signing these documents, volunteers acknowledge their understanding of the content and confirm continued interest in pursuing the study opportunity. Volunteers are also issued a set of these signed documents to keep for their records and retain for future reference. This particular study required an eight hour fast which was conveyed during the phone interview. Additional information about these specific references is noted below.o Page 2 of the Subject Rules and Regulations states, “no other food or beverages will be allowed in the facility.” Only water is permitted and is available in the screening area. Outside food and drinks are prohibited. o Page 1 of the Subject Rules and Regulations states, “The decision to admit you into a study is based upon results of pre-study requirements. There is no compensation for the screening process. No one is assured a place in the study until the first dosing is completed.” Page 7 also states “No one is assured a place in the study until the first dosing is completed.”o The Informed Consent states, “Screening does not mean that you are in the study. Entry into the study depends on the results of your lab tests, study guidelines, and the decision of the study doctor. Even if you pass the screening tests, there is a chance that you will not be in the study. There may be other reasons why you cannot be in the study. The study staff will discuss that with you.”Each study must have its own screening data reviewed by the study doctor to ensure the volunteers meet the entrance criteria provided in the protocol. In order to meet study enrollment timelines, it is necessary to continue screening procedures up until the required number of participants have been selected by the study doctor. PPD sincerely values and appreciates volunteers’ time and interest in clinical research. It is of the utmost importance that volunteers encounter a safe, professional and courteous environment throughout the entire experience. If there are any questions, please contact me at the number listed below.Kind regards.[redacted] Clinics-[redacted] Operations[redacted],[redacted], USAPPDPhone +[redacted]Fax +[redacted]
Complaint: [redacted]
I am rejecting this response because:This company is misleading the volunteers only for his convenience, first of all, I spoke several times with different personnel of PPD staff and I do not recall that any one told me "No one is assured a place in the study until the first dosing is completed.” if I had knowledge about this situation I wouldn't had have the trip from [redacted] to [redacted] in the first place. Second, when I arrived, PPD had me sign the Subject Rules and Regulations and Informed Consent documents, which I signed in good will, after all I was already in their facility and willing to proceed with the study, I never imagined that "Even if you pass the screening tests, there is a chance that you will not be in the study" because the study was already full, so why they required us to go in the first place if they registered more people than the required for the study to be completed. From my point of view, the whole procedure is misleading, unclear and benefits only the PPD research company, without any consideration for the volunteer, as stated at the end of your notification "PPD sincerely values and appreciates volunteers’ time and interest in clinical research. It is of the utmost importance that volunteers encounter a safe, professional and courteous environment throughout the entire experience". For these reasons, I do not accept your apologies and rejecting this response from the business involved.
Regards,
[redacted]
Dear Ms. [redacted],Thank you for contacting PPD this week to share the feedback regarding a customer’s screening experience at our Phase I Clinic on November 24. 2014. Upon further review with staff facilitating procedures that day, the recruiter informed our Subject Relations staff of the...
complaints regarding the screening outcome. We reached out to the volunteer to respond to the concerns and offer clarity to any questions. As part of the initial response steps, we determine whether or not the volunteer has been to the site before. If the volunteer is new to the clinic, additional detail is provided about what to expect during the recruiting and study conduction process. In these specific circumstances, our staff extended an apology for the frustrations and inconvenience encountered. We offered to review actively recruiting studies for potential screening options that aligned with his availability. The offer was declined. During the medical history phone interview and before an appointment is scheduled, the phone recruiter makes the following statements, “There is no compensation for the screening process. No one is assured a place in the study until the first dosing is completed.” This is also conveyed in writing if the volunteer remains qualified upon completion of the initial phone interview and elects to schedule an appointment for the on-site informed consent session often referred to as a screening appointment. During the screening appointment, the recruiter reviews the documents and includes a segment affording volunteers the opportunity to ask questions, is issued a copy of the study dates and the recruiter’s direct contact information should there be any questions after the screening appointment. Before screening procedures are performed, volunteers must read and sign the Subject Rules and Regulations and Informed Consent documents. By signing these documents, volunteers acknowledge their understanding of the content and confirm continued interest in pursuing the study opportunity. Volunteers are also issued a set of these signed documents to keep for their records and retain for future reference. This particular study required an eight hour fast which was conveyed during the phone interview. Additional information about these specific references is noted below.o Page 2 of the Subject Rules and Regulations states, “no other food or beverages will be allowed in the facility.” Only water is permitted and is available in the screening area. Outside food and drinks are prohibited. o Page 1 of the Subject Rules and Regulations states, “The decision to admit you into a study is based upon results of pre-study requirements. There is no compensation for the screening process. No one is assured a place in the study until the first dosing is completed.” Page 7 also states “No one is assured a place in the study until the first dosing is completed.”o The Informed Consent states, “Screening does not mean that you are in the study. Entry into the study depends on the results of your lab tests, study guidelines, and the decision of the study doctor. Even if you pass the screening tests, there is a chance that you will not be in the study. There may be other reasons why you cannot be in the study. The study staff will discuss that with you.”Each study must have its own screening data reviewed by the study doctor to ensure the volunteers meet the entrance criteria provided in the protocol. In order to meet study enrollment timelines, it is necessary to continue screening procedures up until the required number of participants have been selected by the study doctor. PPD sincerely values and appreciates volunteers’ time and interest in clinical research. It is of the utmost importance that volunteers encounter a safe, professional and courteous environment throughout the entire experience. If there are any questions, please contact me at the number listed below.Kind regards.[redacted] Clinics-[redacted] Operations[redacted],[redacted], USAPPDPhone +[redacted]Fax +[redacted]
Complaint: [redacted]
I am rejecting this response because:This company is misleading the volunteers only for his convenience, first of all, I spoke several times with different personnel of PPD staff and I do not recall that any one told me "No one is assured a place in the study until the first dosing is completed.” if I had knowledge about this situation I wouldn't had have the trip from [redacted] to [redacted] in the first place. Second, when I arrived, PPD had me sign the Subject Rules and Regulations and Informed Consent documents, which I signed in good will, after all I was already in their facility and willing to proceed with the study, I never imagined that "Even if you pass the screening tests, there is a chance that you will not be in the study" because the study was already full, so why they required us to go in the first place if they registered more people than the required for the study to be completed. From my point of view, the whole procedure is misleading, unclear and benefits only the PPD research company, without any consideration for the volunteer, as stated at the end of your notification "PPD sincerely values and appreciates volunteers’ time and interest in clinical research. It is of the utmost importance that volunteers encounter a safe, professional and courteous environment throughout the entire experience". For these reasons, I do not accept your apologies and rejecting this response from the business involved.
Regards,
[redacted]