ACRP CCRC, *CCRC Study Set With Complete Solutions.

ACRP CCRC, *CCRC Study Set With Complete Solutions. ADR - Answer Adverse Drug Reaction Audit - Answer Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certificate - Answer Confirmation audit took place Audit Report - Answer Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance Audit Trail - Answer Documentation of audit events Single Blind Study - Answer Subjects Unaware Double Blind Study - Answer Subjects & Researchers are unaware Comparator - Answer Item used as an active control references in a clinical trail Coordinating Committee - Answer Group a sponsor comprises to coordinate multicenter trials Coordinating Investigator - Answer An investigator who oversees multiple sites of a clinical trial (multicenter) IDMC - Answer Independent Data Monitoring Committee, Data & Safety Monitoring Board (DSMB), Data Monitoring Committee: Oversee safety & progress; make recommendations to continue, modify or stop IEC - Answer Independent Ethics Committee; group who oversees protection, rights, safety & well-being of human subjects Investigator's Brochure - Answer Compilation of data on an investigational product used in human subjects Legally acceptable representative - Answer person whom is lawfully able to consent on behalf of another SAE - Answer Serious Adverse Event - Results in death, is life-threatening, requires long-term hospitalization, results in long term disability/hospitalization incapacitation or is a congenital birth defect Source data - Answer original clinical information from source documents (medical record information) Vulnerable subjects - Answer *Hierarchical structure employees *armed forces *detainees *incurable disease pts *homeless *poor *those in nursing home *minors *those unable to give consent ICH - Answer International Conference on Harmonization Principles of ICH & GCP - Answer *Protect research subjects *conduct research as it has been approved *research should be clear, organized & approved by an IRB/IEC IRB / IEC Responsibilities - Answer *Oversee principles of ICH/GCP *Make sure the PI / Co-Is are qualified * Review studies at least once a year Requirements of an IRB - Answer * at least 5 members * one non-scientific member * one non-institute member What needs reported to the IRB? - Answer *Changes / deviations from protocol due to unforeseen hazard * changes to subject risk * adverse events * new info that may impact subject safety Payment to subjects must be.... - Answer prorated & not contingent on subject completing study Investigator Responsibilities - Answer *Maintain delegation long *Ensure staff are trained/informed about the protocol (give delegated tasks) * Ascertain reason study participant withdraws consent while respecting their privacy & rights * Adhere to approved protocol *Document & explain any deviations from approved protocol * Process protocol amendments according to GCP *Manage proper storage & care for trial devices/drugs. (PI can delegate this task to trained professional - PharmD, etc) Protocol amendments should be submitted to - Answer 1. IRB 2. Sponsor 3. Regulatory Authority Changes in risk to subjects... - Answer should be included & approved on an updated ICF - patients enrolled should be re-consented Consenting illiterate subjects - Answer is okay, but must have impartial witness present Necessary aspects of ICF - Answer *Trial involves research *Trial purposes *Treatments - randomization aspect if applicable * Procedures *Subject responsibilities *Experimental Aspects of trial *Risks *Benefits *Alternatives to participating *Compensation * Compensation for trial related outcomes *Voluntary nature of trial *Who has access to direct records *Confidentiality of research records *New information will be made available to subject *Who to Contact *Involuntary termination *Trial Duration *Subjects to be enrolled Non-therapeutic trials can be conducted with consent from legal rep IF - Answer *trial objectives cannot be met by personal subject consent *low risk *trial is not prohibited by law *IRB has approved such inclusion How long must documents be retained per GCP? - Answer At least 2 years after last approved marketing application (organizations/sponsors, etc usually set a longer required period of 5-7 years) When to submit SAE to sponsor? - Answer Immediately (usually within 24 hours) Sponsors role - Answer *Complete & ensure SOPs are followed *seeks agreements from all parties *may use CRO to oversee; however, the sponsor is ultimately responsible CRO - Answer Contract Research Organization Sponsor/Investigator agreement should contain - Answer 1. Agreement to comply w/ GCP (adhere to protocol & IRB) 2. Agree to comply with data recording 3. Agree to permit monitoring 4. Agree to retain documents for specified length of time *Agreement should be signed by both parties Purpose of Trial monitoring - Answer *Ensure rights & safety of subjects are protected