Which of the following is considered a minor change that would not require formal IACUC review and approval quizlet?

heterogeneous assay (inversely proportional)- antibody is immobilized (coated wells), sample diluted in buffer, enzyme-labeled drug is added, incubate, wash, add substrate to change color, incubate, add stop reagent, read absorbance. MORE color = less binding of drug sample, more binding of labeled drug, therefore LESS color = more drug binding, less labeled drug

oral, inhalation, intravenous, intramuscular, rectal, sublingual, intrathecal, transdermal, intraocular, intranasal, subcutaneous, topical

prior to analysis the sample should be stored in a secure location with an unbroken seal, dilutions, measurement of pH and weight, duration time for processes such as extractions, amplifications, prep vol of reagents and stds., each step must be documented, for confirmation purposes another analyst should be there to observe OR another confirmatory test can be performed, all evidence should be documented with a sample ID #, date of analysis, ID of instruments used, approved methods number

Title of SOP, author, issue date, ID #, Page x of y, approval signature (senior lab official), some subsections include:
Scope--elaborates on title
Referenced Docs--source providing info for the SOP (federal standards, journal articles, SOP's of other labs)
Defiinitions/Terminology--unfamiliar terms, common abbreviations
Summary of Methods--briefly describes equip and general procedures
Inferences--compounds that will interfere with results are noted
Apparatus and Materials--lists devices, columns, detectors used in analysis, also should include syringes, bottles, vials
Reagents--solvents, stock standards, reference standards, calibration standards, internal standards, surrogates, include conc. hazards, chemical grade, storage conditions
Sample Collection, Preservation, and Handling--specific methods for handling a sample
Procedures--Instrument or method calibration, sample prep and analysis, troubleshooting, calculations
Quality Control--Procedures est. to demonstrate that instrument calibration, sample prep and analysis are preformed correctly.
Method Performance--The min detectable level IMDL) of a substance in diff. matrices, % of recovered chemical
Miscellaneous--flow charts, diagrams

--this includes: the #, weight range, sex, source of supply, species, strain, sub-strain and age of all animals used

--IACUC approval-use of animals must be reviewed and approved

--info presented to the IACUC would include: conditions, descript of animal cages, feeding, provisions, treatments and experimental use, disposal of study animals, disposal of animal by-products, procedures for adverse events.

--use of human subjects requires Institutional Review Board (IRB) to approve

--#, sex, age, and criteria for selection of human subjects. use of fetuses, children, pregnant women, and prisoners is restricted

--An informed consent form must be read, signed and dated by all human participants. Must be written so all participants understand it.

--Procedure for ID to the system, using specific criteria to select the test system

retention of all experimental records is necessary, this includes hand-written observation, raw data obtained, protocols, data, documentation, reports an even specimens must be saved for some time (non-clinical study w/ application= 5, no application = 2 yrs) -this is mandated by the FDA

EPA requires 2-5 yrs retention of record based on whether or not the results of the study are submitted to the EPA, clinical drug regulations state that records must be retained for two years after marketing approval or notification that the study was discontinued

Protocol Approval - signed and dated by the sponsor and study director. Also signatures by quality assurance officers, consultants and others

Statistical Methods-statistical methods should be summarized and rationale for their use included.

Appendices--Ex. of the Informed Consent Form, SOP's, Ex of Owner consent form (animal), descript of collection sites, descript of special equip, validation studies, investigator qualifications

a case identifier, description of the evidence examined, a description of methodology, the locus used, results/conclusions, interpretive statement, date issued, disposition of evidence, a signature and title

in addition, ISO17025 requires that: total # of pages on any hard copies of the report, the name and address of the client, unique ID # on report, descrip of the sampling plan, date of receipt of test item

this type of audit can be a way to prepare for inspection by a regulatory agency, this can be done by lab personnel, one who is familiar with the equipment, but not specifically involved in that program.

Typical checklist includes:
names of staff members
must haves--unique ID, COC, proper seal, samples protected, ID's based on 2 independant assays, amount of sample needed, security

Receiving through confirmation:
check new SOP's, interview employees, check freezers and fridge, check for samples left out or unattended, check receiving paper work, verify COC

Check written policies---contamination issues, sample tampering, breakage, ect

discard expired chemicals and stock soltns, remove equip and chemicals that are not used, est that equip and instruments needed are available, check equip files to be sure they are all up to date, check for labels on instruments (ID#, install date, date of last maitenance, etc), check that all bottles are labeled, place samples analyzed, reagent bottles in their proper locations, discard samples and records no longer needed

SOPS, sample prep, laboratory policies, employee records and training, logs of samples received, records of past issues, corrective actions, maitenance records, laboratory notebooks, validation records, variance letters from accreditation body that approve alt test methods, calibration records, COC

extent to which other drugs and metabolites interfere and may give false positive assay results, may be concentraiton dependant

Cross-reacting Substances
Amphet/Methamp MDA, MDMA, Ephedrine, pseudophedrine,
fenfluramine, phenylpropanolamine,
phentermine, phenmetrazine

Benzodiazepines Chlorpromazine

Cocaine (BZE) Ecgonine, ecgonine methyl ester, cocaine

THC (cannabinoids) IBU, naproxen, ketoprofen, tolmetin,
acetylsalicylic acid (aspirin)

LSD Ergotamine, tricyclic-antidepressants,
verapmil, sertraline, fentanyl

Morphine Codeine, hydrocodeine, thebaine,
hydrocodone, dihydromorphine,
hydromorphone, oxycodone, oxymorphone,
meperdine, norcodeine

PCP TCp, Diphenhydramine, Dextromethorphan

radiation is focused on the sample then passes through a monochromator with a fixed diffraction grating. The dispersed radiation is reflected onto a photodiode transducer that is composed of hundreds of photodiode array transducers mounted on a silicon chip. The slit width of the monochromator is adjusted to the width of one of the diodes so the output of each diode corresponds to radiation of a diff wavelength, by scanning these outputs sequentially a spectrum can be obtained.

Advantages: quick data accumulation, simple design, few moving parts, little calibration needed, minimal maitenance required

Disadvantages: limited resolution 1-2 nm, low specificity, therapeutic drugs are often too low to detect and metabolites can retain the chromophore which can contribute to the absorbance spectrum. This is why this test is only a screening test NOT a confirmatory test.

Forensic Science applications: several drug classes have good UV abs, including: barbituates (phenobarbital), benzodiazepines (diazepam), phenothiazines, tricyclic antidepressants

a sample is injected onto the column through an injection port using a syringe. Ind. components are separated on the column are detected as they emerge by a detector.

Components----
Eluent--this can be water, buffer soltn, organic mixtures. HPLC grade liquids should be used to minimize the presence of impurities. They should be filtered and degassed.
Effect of pH--you want to avoid ionization of the compound. Adding a buffer at the required pH usually prevents ionization. For acids, buffer pH=3 added to mobile phase, for bases, buffer of greater than pH 8 should not be used bc this will deteriorate the column. Therefore an ion pair agent is employed and the pH of the mobile phase is kept acidic. ex. sulfonic acid and N+

Pump--this delivers the eluent to the column at a controlled rate and higher pressure. Flow rates are typically .5-2 ml/min. The flow rate must be continuous.
Injection system-uses a fixed loop that is filled with excess sample and holds a precise amount of soltn int the injection column.

Columns--There are two types of columns 1)absorption or normal phase- adsorbent material is used, usually silica, solutes bind to the column based on solubilities-polar compounds have long retention times, works best for non-polar substances 2) partition or reverse phase-in these polar compounds elute first, and non-polar compounds are strongly bound

Detectors--
UV-Vis, Dioade array, Fluorescence, Electrochemical, refractive index, mass spectrometer

descriptive title, study objective, ID of test and control articles, sponsor,testing facilities, other participants and justification of the study, detailed description of experiment, experimental design, start/finishdates, approval, statistical methods used, appendicies, amendments, deviations

prior to analysis the sample should be stored in a secure location with an unbroken seal, dilutions, measurement of pH and weight, duration time for processes such as extractions, amplifications, prep vol of reagents and stds., each step must be documented, for confirmation purposes another analyst should be there to observe OR another confirmatory test can be performed, all evidence should be documented with a sample ID #, date of analysis, ID of instruments used, approved methods number

Title of SOP, author, issue date, ID #, Page x of y, approval signature (senior lab official), some subsections include:
Scope--elaborates on title
Referenced Docs--source providing info for the SOP (federal standards, journal articles, SOP's of other labs)
Defiinitions/Terminology--unfamiliar terms, common abbreviations
Summary of Methods--briefly describes equip and general procedures
Inferences--compounds that will interfere with results are noted
Apparatus and Materials--lists devices, columns, detectors used in analysis, also should include syringes, bottles, vials
Reagents--solvents, stock standards, reference standards, calibration standards, internal standards, surrogates, include conc. hazards, chemical grade, storage conditions
Sample Collection, Preservation, and Handling--specific methods for handling a sample
Procedures--Instrument or method calibration, sample prep and analysis, troubleshooting, calculations
Quality Control--Procedures est. to demonstrate that instrument calibration, sample prep and analysis are preformed correctly.
Method Performance--The min detectable level IMDL) of a substance in diff. matrices, % of recovered chemical
Miscellaneous--flow charts, diagrams

--this includes: the #, weight range, sex, source of supply, species, strain, sub-strain and age of all animals used

--IACUC approval-use of animals must be reviewed and approved

--info presented to the IACUC would include: conditions, descript of animal cages, feeding, provisions, treatments and experimental use, disposal of study animals, disposal of animal by-products, procedures for adverse events.

--use of human subjects requires Institutional Review Board (IRB) to approve

--#, sex, age, and criteria for selection of human subjects. use of fetuses, children, pregnant women, and prisoners is restricted

--An informed consent form must be read, signed and dated by all human participants. Must be written so all participants understand it.

--Procedure for ID to the system, using specific criteria to select the test system

retention of all experimental records is necessary, this includes hand-written observation, raw data obtained, protocols, data, documentation, reports an even specimens must be saved for some time (non-clinical study w/ application= 5, no application = 2 yrs) -this is mandated by the FDA

EPA requires 2-5 yrs retention of record based on whether or not the results of the study are submitted to the EPA, clinical drug regulations state that records must be retained for two years after marketing approval or notification that the study was discontinued

Protocol Approval - signed and dated by the sponsor and study director. Also signatures by quality assurance officers, consultants and others

Statistical Methods-statistical methods should be summarized and rationale for their use included.

Appendices--Ex. of the Informed Consent Form, SOP's, Ex of Owner consent form (animal), descript of collection sites, descript of special equip, validation studies, investigator qualifications

a case identifier, description of the evidence examined, a description of methodology, the locus used, results/conclusions, interpretive statement, date issued, disposition of evidence, a signature and title

in addition, ISO17025 requires that: total # of pages on any hard copies of the report, the name and address of the client, unique ID # on report, descrip of the sampling plan, date of receipt of test item

this type of audit can be a way to prepare for inspection by a regulatory agency, this can be done by lab personnel, one who is familiar with the equipment, but not specifically involved in that program.

Typical checklist includes:
names of staff members
must haves--unique ID, COC, proper seal, samples protected, ID's based on 2 independant assays, amount of sample needed, security

Receiving through confirmation:
check new SOP's, interview employees, check freezers and fridge, check for samples left out or unattended, check receiving paper work, verify COC

Check written policies---contamination issues, sample tampering, breakage, ect

discard expired chemicals and stock soltns, remove equip and chemicals that are not used, est that equip and instruments needed are available, check equip files to be sure they are all up to date, check for labels on instruments (ID#, install date, date of last maitenance, etc), check that all bottles are labeled, place samples analyzed, reagent bottles in their proper locations, discard samples and records no longer needed

SOPS, sample prep, laboratory policies, employee records and training, logs of samples received, records of past issues, corrective actions, maitenance records, laboratory notebooks, validation records, variance letters from accreditation body that approve alt test methods, calibration records, COC

1: High abuse, no medical, no safety
2: High abuse, medical use, high addiction
3: Less high abuse, medical use, moderate addiction
4: Lower abuse, medical use, limited addiction
5: Low abuse, medical use, little addiction

Effects: Analgesia, euphoria, cough suppression, mitigate diarrhea, miosis
From: opium plant, or produced synthetically
Used: intravenously, inhalation, orally, transdermally
Actions: Modulates membrane receptors, inhibits neuronal transmission, inhibits adenylyl cyclase
Death: respiratory depression from high doses, suffocation from vomiting

Strengths: sensitive, strong assay response, resistant to matrix effects, bile and blood, amphetamines, barbiturates, opiates, PCP, cannabinoids, benzos, LSD, for ricin in urine and THC in hair
Weakness: radioactive waste, difficult to automate

extent to which other drugs and metabolites interfere and may give false positive assay results, may be concentraiton dependant

Cross-reacting Substances
Amphet/Methamp MDA, MDMA, Ephedrine, pseudophedrine,
fenfluramine, phenylpropanolamine,
phentermine, phenmetrazine

Benzodiazepines Chlorpromazine

Cocaine (BZE) Ecgonine, ecgonine methyl ester, cocaine

THC (cannabinoids) IBU, naproxen, ketoprofen, tolmetin,
acetylsalicylic acid (aspirin)

LSD Ergotamine, tricyclic-antidepressants,
verapmil, sertraline, fentanyl

Morphine Codeine, hydrocodeine, thebaine,
hydrocodone, dihydromorphine,
hydromorphone, oxycodone, oxymorphone,
meperdine, norcodeine

PCP TCp, Diphenhydramine, Dextromethorphan

radiation is focused on the sample then passes through a monochromator with a fixed diffraction grating. The dispersed radiation is reflected onto a photodiode transducer that is composed of hundreds of photodiode array transducers mounted on a silicon chip. The slit width of the monochromator is adjusted to the width of one of the diodes so the output of each diode corresponds to radiation of a diff wavelength, by scanning these outputs sequentially a spectrum can be obtained.

Advantages: quick data accumulation, simple design, few moving parts, little calibration needed, minimal maitenance required

Disadvantages: limited resolution 1-2 nm, low specificity, therapeutic drugs are often too low to detect and metabolites can retain the chromophore which can contribute to the absorbance spectrum. This is why this test is only a screening test NOT a confirmatory test.

Forensic Science applications: several drug classes have good UV abs, including: barbituates (phenobarbital), benzodiazepines (diazepam), phenothiazines, tricyclic antidepressants

a sample is injected onto the column through an injection port using a syringe. Ind. components are separated on the column are detected as they emerge by a detector.

Components----
Eluent--this can be water, buffer soltn, organic mixtures. HPLC grade liquids should be used to minimize the presence of impurities. They should be filtered and degassed.
Effect of pH--you want to avoid ionization of the compound. Adding a buffer at the required pH usually prevents ionization. For acids, buffer pH=3 added to mobile phase, for bases, buffer of greater than pH 8 should not be used bc this will deteriorate the column. Therefore an ion pair agent is employed and the pH of the mobile phase is kept acidic. ex. sulfonic acid and N+

Pump--this delivers the eluent to the column at a controlled rate and higher pressure. Flow rates are typically .5-2 ml/min. The flow rate must be continuous.
Injection system-uses a fixed loop that is filled with excess sample and holds a precise amount of soltn int the injection column.

Columns--There are two types of columns 1)absorption or normal phase- adsorbent material is used, usually silica, solutes bind to the column based on solubilities-polar compounds have long retention times, works best for non-polar substances 2) partition or reverse phase-in these polar compounds elute first, and non-polar compounds are strongly bound

Detectors--
UV-Vis, Dioade array, Fluorescence, Electrochemical, refractive index, mass spectrometer

prior to analysis the sample should be stored in a secure location with an unbroken seal, dilutions, measurement of pH and weight, duration time for processes such as extractions, amplifications, prep vol of reagents and stds., each step must be documented, for confirmation purposes another analyst should be there to observe OR another confirmatory test can be performed, all evidence should be documented with a sample ID #, date of analysis, ID of instruments used, approved methods number

Title of SOP, author, issue date, ID #, Page x of y, approval signature (senior lab official), some subsections include:
Scope--elaborates on title
Referenced Docs--source providing info for the SOP (federal standards, journal articles, SOP's of other labs)
Defiinitions/Terminology--unfamiliar terms, common abbreviations
Summary of Methods--briefly describes equip and general procedures
Inferences--compounds that will interfere with results are noted
Apparatus and Materials--lists devices, columns, detectors used in analysis, also should include syringes, bottles, vials
Reagents--solvents, stock standards, reference standards, calibration standards, internal standards, surrogates, include conc. hazards, chemical grade, storage conditions
Sample Collection, Preservation, and Handling--specific methods for handling a sample
Procedures--Instrument or method calibration, sample prep and analysis, troubleshooting, calculations
Quality Control--Procedures est. to demonstrate that instrument calibration, sample prep and analysis are preformed correctly.
Method Performance--The min detectable level IMDL) of a substance in diff. matrices, % of recovered chemical
Miscellaneous--flow charts, diagrams

--this includes: the #, weight range, sex, source of supply, species, strain, sub-strain and age of all animals used

--IACUC approval-use of animals must be reviewed and approved

--info presented to the IACUC would include: conditions, descript of animal cages, feeding, provisions, treatments and experimental use, disposal of study animals, disposal of animal by-products, procedures for adverse events.

--use of human subjects requires Institutional Review Board (IRB) to approve

--#, sex, age, and criteria for selection of human subjects. use of fetuses, children, pregnant women, and prisoners is restricted

--An informed consent form must be read, signed and dated by all human participants. Must be written so all participants understand it.

--Procedure for ID to the system, using specific criteria to select the test system

retention of all experimental records is necessary, this includes hand-written observation, raw data obtained, protocols, data, documentation, reports an even specimens must be saved for some time (non-clinical study w/ application= 5, no application = 2 yrs) -this is mandated by the FDA

EPA requires 2-5 yrs retention of record based on whether or not the results of the study are submitted to the EPA, clinical drug regulations state that records must be retained for two years after marketing approval or notification that the study was discontinued

Protocol Approval - signed and dated by the sponsor and study director. Also signatures by quality assurance officers, consultants and others

Statistical Methods-statistical methods should be summarized and rationale for their use included.

Appendices--Ex. of the Informed Consent Form, SOP's, Ex of Owner consent form (animal), descript of collection sites, descript of special equip, validation studies, investigator qualifications

a case identifier, description of the evidence examined, a description of methodology, the locus used, results/conclusions, interpretive statement, date issued, disposition of evidence, a signature and title

in addition, ISO17025 requires that: total # of pages on any hard copies of the report, the name and address of the client, unique ID # on report, descrip of the sampling plan, date of receipt of test item

this type of audit can be a way to prepare for inspection by a regulatory agency, this can be done by lab personnel, one who is familiar with the equipment, but not specifically involved in that program.

Typical checklist includes:
names of staff members
must haves--unique ID, COC, proper seal, samples protected, ID's based on 2 independant assays, amount of sample needed, security

Receiving through confirmation:
check new SOP's, interview employees, check freezers and fridge, check for samples left out or unattended, check receiving paper work, verify COC

Check written policies---contamination issues, sample tampering, breakage, ect

discard expired chemicals and stock soltns, remove equip and chemicals that are not used, est that equip and instruments needed are available, check equip files to be sure they are all up to date, check for labels on instruments (ID#, install date, date of last maitenance, etc), check that all bottles are labeled, place samples analyzed, reagent bottles in their proper locations, discard samples and records no longer needed

SOPS, sample prep, laboratory policies, employee records and training, logs of samples received, records of past issues, corrective actions, maitenance records, laboratory notebooks, validation records, variance letters from accreditation body that approve alt test methods, calibration records, COC

Which of the following significant changes to a protocol could be administratively approved in principle by VVC quizlet?

What are some elements of the protocol that the IACUC will review?

Which task is not a function of IACUC?

Which of the following is an IACUC responsibility?