CHOP Facts
The CEO of CHOP
Who is Madeline Bell?
SOP 404: This should be submitted at least 30 days before the study approval period ends (expiration date) in order to provide sufficient time for review.
What is the continuing review?
This is required for use or disclosure of private health information (PHI) for the purposes of research. It can be in a stand-alone document but is often combined in the informed consent document.
What is HIPPA Authorization?
This manager has 3 children and they are all boys.
Who is Tonia?
This person should be qualified by education, training and experience to assume responsibility for the proper conduct of the trial and should provide evidence of such qualifications.
Who is the Principal Investigator?
CHOP is widely recognized as the first of this.
What is the First Children's Hospital?
SOP 701: A document used in the consent process with Limited English Proficiency subjects when the short form process is implemented.
What is a study summary document?
Two basic elements of informed consent involve disclosing "___" and "___" which describe any foreseeable discomforts to the subject and what they might gain from participating.
What are risks and benefits?
This manager loves playing scrabble!
Who is Donna?
The investigator must always follow the protocol but these may occur only when necessary to eliminate an immediate hazard(s) to trial participants. If they occur frequently or are in response to a hazard, a subsequent protocol amendment may be necessary.
What are protocol deviations?
What is gene therapy?
SOP 408: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
What is an Adverse Event?
The consent document should be written using lay terms, and in a language the subject understands, which is also called this.
What is plain language?
This manager graduated from Cardinal O'Hara Highschool in Delco.
Who is Tina?
The responsibility of this entity entails the implementation of risk-proportionate approaches to ensure the rights, safety and well-being of the trial participants and the reliability of the trial results throughout the clinical trial life cycle.
Who is the sponsor?
The Roberts Center for Pediatric Research opened in "___".
What is 2017.
SOP 501: Pregnant women, wards, and children are examples of this type of population.
What are Vulnerable Subjects?
After reviewing the consent form, the investigators can use "___" to assess comprehension. Questions should be open-ended and should not involve yes or no questions.
What is the talk back method?
This manager met her two best friends in high school.
Who is Donna?
These should be attributable, legible, contemporaneous, original, accurate and complete.
CHOP reports this many total outpatient and primary care visits annually (rounded number).
What is 2 million?
SOP 412: A medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.
What is a Humanitarian Use Device (HUD)?
This visual can be used on a consent form as a representation to explain risk. The IRB states: "low numeracy is an even bigger problem than low literacy level."
What are graphical representations?
This manager was as a Magnet committee member back in 2004 when CHOP obtained their first accreditation. We were the first pediatric hospital in PA to receive this status.
Who is Tina?
This should be developed and updated as significant new information on the investigational product becomes available.
What it the investigator's brochure?