IRB and Clinical Trials: Main Disclosable Financial Interests, Membership, and Regulations, Exams of Nursing

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CCRP CERTIFICATION EXAM Q & A FEB 2024 UPDATE What are the five types of SAEs? ✔️1) life threatening 2) results in death 3) hospitalization 4) results in disability 5) birth defect What are the SAE reporting timelines for investors and sponsors in drug trials? ✔️Investigators to sponsor= 24 hrs - whether or not it's drug related - must include an assessment of causality Sponsor to FDA and all other investigators =15 calendar days -qualifies for reporting: 1) unexpected and serious 2) SAEs from other studies using same drug 3) findings from animal testing 4) increased rate of occurrence What is an SAE for device trials? ✔️UADE Unanticipated adverse device event What are the UADE reporting timelines for investigators and sponsors? ✔️Investigator to sponsor AND IRB= 10 working days Sponsor to FDA and all reviewing IRBs = 10 working days What does part of the code of regulations discusses participation of pregnant women in clinical trials? ✔️45 CFR 46 subpart B What part of the code of regulations discusses children? ✔️45 CFR 46 subpart D Considerations in order for pregnant women to participate in clinical research? ✔️1) The risk to the fetus may result in direct benefit to the WOMAN or the FETUS. Or the risk to the fetus is not greater than minimal and there are no other means to obtain the knowledge. 2) benefits only to fetus= consent from BOTH father and mother required What are the four categories the federal regulations require IRBs to classify research children? ✔️1) Research not involving minimal risk 2) Research involving greater than minimal risk, but may involve direct benefit to the individual subject - the risk is justified by the potential benefit to the subject AND - the risk/benefit is at least favorable as any available SOC 3) Research involving greater than minimal risk w no direct benefit to individual subject but may yield generalized knowledge about the subjects disorder or condition. -risk represents only a minor increase over minimal risk -comparable to SOC -likely to yield knowledge 4) Research that is not otherwise approvable but which presents an opportunity to understand, prevent, or alleviate a serious problem affecting children. Who decides weather one or both parents or assent are required to consent for children participating in clinical research? ✔️IRB What considerations should the IRB use to determine the assent requirement? ✔️1) The nature of the research 2) childs age, status and condition 3) whether some or all of the children participating are capable of assenting to participation What are special considerations for wards of the state? ✔️1) when the research involves greater than minimal risk with no direct benefit to the individual, the research must Either be related to the Childrens status as wards OR be in a setting where the majority of children are not wards IDE Application stands for: ✔️Investigational Device Exemption Application IDE: Significant Risk ✔️Presents a potential for serious risk to health, safety, and welfare to a participant and is: • An implant • Used in supporting or sustaining human life, or • Of substantial importance in diagnosing, curing, mitigating, or treating disease, or preventing impairment of human health. Good rule of thumb: anything put into the body on a semi-permanent or permanent basis. -first submitted to the FDA for review and approval of the IDE application, then to the IRB IDE: Non - Significant Risk ✔️Abbreviated Requirements for Non- significant Risk studies include: • Sponsor submits study protocol to IRB and includes a statement of why the investigation does not pose significant risk. • If the IRB approves the investigation as Non- Significant Risk (NSR), then it may begin. • Abbreviated IDE requirements are handled locally. • No IDE submission to the FDA is needed. FDA IDE Exemptions ✔️-A device in commercial distribution before May 28, 1976 -diagnostic device -custom device - vet or lab use Who is responsible for making the initial determination whether a device is SR or NSR? ✔️Sponsors. and they present to IRB for aproval IRB record retention requirement ✔️3 years after study completion What are the two methods that reduce bias? ✔️Blinding and Randomization What are the three primary responsibilities of an investigator? ✔️OP Control 1) Oversee conduct of the trial under appropriate regulation 2) Protect the rights, safety, and welfare of subjects 3) Control the use of IP FDA Form 1572 includes: ✔️Statement of Investigator to comply with FDA regulations COPPERMC C-conduct the studies following the current protocol O-obtain informed consent P-personally supervise the studies P-properly train staff and employees E-ensure that an IRB oversees R- report AEs M-maintain adequate records C-comply with all other requirements ALCOA ✔️Attributable, Legible, Contemporaneous, Original, Accurate Essential Documents: pre-trial- what documents are with sponsor but not with the investigator? ✔️1)Sample of Investigational product labels 2) Master Randomization list 3) Pre-trial monitoring report 4) Certificates of analysis Essential documents: pre-trial- what documents are held by a third party? ✔️1) decoding procedure 2) master randomization list (can also be held by the sponsor) Essential Documents: pre- trial- what documents are held by the investigator and not the sponsor? ✔️1) Advertisements Essential documents: during trial- what documents are held by the investigator but not the sponsor? ✔️1) signed informed consent 2) source documents 3) copy of completed CRFs (original is w sponsor) 4) copy of CRF corrections (original is w sponsor) 5)subject ID list 6) subject enrollment list Essential Documents: during trial- what documents are held by the sponsor and not the investigator? ✔️1) Certificates of Analysis of any new batches 2) Originals of completed CRFs (copy at investigator) 3) Originals of CRF corrections (copy at investigator) 4) Monitoring visit reports Essential documents: after trial- what documents are held by the investigators and not the sponsors? ✔️1) investigational product destruction (if destroyed at site) 2) subject ID code list 3) Final report by IRB 4) Clinical study report (if applicable) Essential Documents: after trial- what documents are stored at sponsor and not with investigators? ✔️1) Investigational Product Destruction (if not destroyed at site) 2) Audit certificate 3) Final close out monitoring report 4) Treatment allocation and Decoding documents 5) clinical study report Essential Documents definition ✔️Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. Time required to keep clinical trial records at site ✔️2 years after FDA approval OR 2 years after study ended Quality Control (QC) vs Quality Assurance (QA) ✔️QC focuses on identification and correction vs. QA focuses on prevention CAPA stands for ✔️Corrective and preventive action CAPA is ✔️A process to identify root cause of issues or problems and actions to resolve them Who does the sponsor notify that a study has been terminated? How many days? ✔️Sponsors notify FDA within 30 working days of completion. The sponsor is also required to submit a final report to the FDA and all reviewing IRBs and participating investigators within 6 months. Different types of INDs ✔️1) Commercial- for a sponsor 2) Investigator IND- for a sponsor-investigator 3) Emergency Use IND- for the use of an investigational drug in a situation that does not allow time of submission of an IND in a normal route 4) treatment IND- for investigational drug that shows promise in clinical testing for serious or immediately life-threatening conditions while the final clinical testing and FDA review take place IND content ✔️1) Animal pharmacology and toxicology studies- pre- clinical data 2) Manufacturing information 3) Clinical protocols and investigator information - protocols, IB, Form 1571, Form 1572 Form 1571 ✔️Cover sheet for an IND application What happens after an IND is submitted? ✔️30 day hold period - there is a 30 calendar day period for the FDA to review the IND for safety. The sponsor or sponsor-investigator must wait until after this 30 calendar days period before initiating clinical trials. IDE ✔️Investigational Device Exemption. Form 3500A ✔️Mandatory safety reporting by user facilities, distributors, and manufacturers Form 3500B ✔️Voluntary reporting for consumers. This is a consumer- friendly version of the Form 3500 reporting form 21 CFR 11 ✔️Electronic Records; Electronic Signatures closed system ✔️access to the system is controlled by persons who oversee the content Open system ✔️is when access to the system is not controlled by persons who oversee the content. In an open system, records can be read, modified or compromised by others. FDA regulations emphasis the need for the use of appropriate digital signatures Time required for sponsor keep clinical trial records for drug trials ✔️2 years after FDA approval or 2 years after last shipment and delivery of the IP and FDA was notified Time required for sponsor keep clinical trial records for device trials ✔️2 years after study completion or 2 years after the date that the records are no longer required for a PMA or after the date on the notice of completion of protocol requirements Pharmacokinetic (PK) studies ✔️are conducted to learn what happens to the new drug in a living organism. Pharmacodynamics (PD) studies ✔️what the drug does to the body Phase 0 ✔️PK and PD studies (N=10-15) Phase 1 ✔️Safety (N=20-80) Can also learn dosing interval Phase 2 ✔️Efficacy(N=100-200) time: several months to two years, purpose: short-term safety but mainly effectiveness Phase 3 ✔️Pivotal (N=300-3,000) time: one to four years, purpose: compared against standard of care Phase 4 ✔️post marketing surveillance Class I Medical Device definition ✔️This class of medical device is very simple by design and has a very low potential to cause harm. Example- gloves and bandages Exempt from the 501(k) clearance and premarket approval (PMA) process FDA 501(k) ✔️requires device manufacturers to notify FDA at least 90 days prior to marketing a device. Upon notified FDA will determine whether the device is equivalent to previously approved devices and allow the device to be sold Class II Medical Devices ✔️considered to pose potential risks great enough to warrant higher regulation; includes more sterilization equipment and chemical indicators; 501k required Examples: x-ray machines, infusion pumps, powered wheelchairs Requires 501(k) clearance submission Class III Medical Devices ✔️high risk devices such as implants, heart valves, pacemakers, etc.; 501k required; subject to high performance standards and post-market surveillance FDA requires a premarket approval application (PMA) to be submitted for most Class III devices. The FDA reviews PMA similar way to the new drug application (NDA) to ensure safety and effectiveness 21 CFR 812 ✔️Investigational Device Exemption (IDE) What are the two phases for Medical Device Clinical Trials ✔️Pilot (sm # of subjects) -> Pivotal (lg #of subjects) -> data analysis can be combined Differences between SR and NSR studies ✔️Significant Risk studies: - Follow all IDE regulations - Have a IDE application approved by FDA prior to study start Non-significant studies: -Follow abbreviated requirements -Do NOT need an IDE application approved by the FDA - Sponsors and IRBs do not have to report to FDA prior to study start Drug or device? Form 1572 ✔️Drug