Mega Socra Ccrp Updated Exam Questions And Correct Answers

Mega Socra Ccrp Updated Exam Questions And Correct Answers Phase 0 clinical trial (PK) Pharmokinetics and (PD) Pharmodynamics. Very small in #'s 1st in Humans -is it consumable for humans? ✔✔✔ Phase 0 clinical trial True or false: the federal food, drug, and cosmetic act is United States, federal law enacted by Congress? ✔✔✔ True True or false: the FD&C act can be found in the US code, which contains all general in permanent US laws beginning at 21 U.S.C.301? ✔✔✔ True Food, Drug, and Cosmetic Act of 1938 ✔✔✔ Requires new drugs must be proven safe before marketing 21 CFR 10.115 what are Guidance documents ✔✔✔ Documents prepared for FTA, staff, applicants, sponsors, and the public that describe the agencies interpretati on or policy and regulatory issues. Phase 1 clinical trials Safety phase Small in #'s Healthy subjects used -Is it safe? ✔✔✔ Phase 1 clinical trial Phase 2 clinical trials Efficacy "Proof of concept" Larger #'s Those with the disease (issue) needing treatment ✔✔✔ Phase 2 clinical trial Phase 3 clinical trials "Pivotal Study" Larger #'s Those with the disease -seeks statistical evidence ✔✔✔ Phase 3 clinical trials Phase 4 clinical trials "Post market surveilla nce" General public Longer years of data collection Post regulatory approval -what are the long term effects ✔✔✔ Phase 4 clinical trial What is 21 CFR 10.115 ✔✔✔ The good guidance practice regulations Medical device classifications Pilot (smaller #'s) & Pivotal trials (larger #'s) -No phases only Classes 1 -3✔✔✔ Medical device classifications Medical device class 1 General controls Nothing required form wise Bandaids, gloves, depressors example *minimal potential harm to patient ✔✔✔ Medical device class 1 Medical device class 2 General controls & special controls Pumps, X -ray machines, monitors, POC devices May need 501K clearance *These devices have a moderate to high risk to the patient and/or user. ✔✔✔ Medical device class 2 Medical device class 3 General controls & premarket approval & drug eluting Pacemakers, implants, drug eluding stents *These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury ✔✔✔ Medical device class 3 Essential documents ✔✔✔ Instigators brochure Insurance statement Pretrial monitoring report, Trial initiation monitoring report Clinical study report Essential document -investigators brochure Document showing relevant and current scientific info about the investigational product provided by the investigator ✔✔✔ Essential document -investigators brochure Essential document -insurance statement Document that compensation to subject for trial relat ed injury, will be available ✔✔✔ Essential document -insurance statement Essential document -pretrial monitoring report Document that the site is suitable for the trial. ✔✔✔ Essential document -pretrial monitoring report Essential document -trial initiation m onitoring report Document that the trial procedures were reviewed with the investigator and the staff ✔✔✔ Essential document -trial initiation monitoring report Essential document -clinical study report Documents the results and interpretation of the trial .✔✔✔ Essential document -clinical study report Alcoa Attributable Legible Contemporaneous Original Accurate. CFR 312.62 ✔✔✔ ALCOA The investigator or those the investigator assigns and delegates to the task.