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SOCRA certification: Class Quizzes Week 1-5. Questions and answers, verif/ LATEST EXAM PREDICTIONS UPDATES, APPROVED. verified/
[Show more]SOCRA certification: Class Quizzes Week 1-5. Questions and answers, verif/ LATEST EXAM PREDICTIONS UPDATES, APPROVED. verified/
[Show more]CITI - SoCRA Researchers, Questions 
and answers, rated A+ 
HIPAA allows healthcare organizations to control many information decisions. However, where the 
patient retains control, which of the following is true? - -If a person has a right to make a healthcare 
decision, then generally that pers...
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and answers, rated A+ 
HIPAA allows healthcare organizations to control many information decisions. However, where the 
patient retains control, which of the following is true? - -If a person has a right to make a healthcare 
decision, then generally that pers...
CITI - SoCRA - GCP for Clinical Trials 
with Investigational Drugs and Biologics 
(ICH Focus), Questions and answers/ 
VERIFIED. 
Which of the following lists the three principles included in the Belmont Report? - -Respect for 
Persons, Beneficence, Justice 
Which of the following is an example ...
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with Investigational Drugs and Biologics 
(ICH Focus), Questions and answers/ 
VERIFIED. 
Which of the following lists the three principles included in the Belmont Report? - -Respect for 
Persons, Beneficence, Justice 
Which of the following is an example ...
SOCRA 2, Exam Review Questions and 
answers, rated A+ 
clinical investigation - -______means any experiment that involves a test article and one or more 
human subjects 
5 working days - -If immediate use of the test article is not sufficient to obtain the independent 
determination typically req...
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clinical investigation - -______means any experiment that involves a test article and one or more 
human subjects 
5 working days - -If immediate use of the test article is not sufficient to obtain the independent 
determination typically req...
CITI - SoCRA - GCP for Clinical Trials 
with Investigational Drugs and Biologics 
(ICH Focus), Questions and answers, 
VERIFIED/ 
Which of the following lists the three principles included in the Belmont Report? - -Respect for 
Persons, Beneficence, Justice 
Which of the following is an example ...
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with Investigational Drugs and Biologics 
(ICH Focus), Questions and answers, 
VERIFIED/ 
Which of the following lists the three principles included in the Belmont Report? - -Respect for 
Persons, Beneficence, Justice 
Which of the following is an example ...
SOCRA Practice 4, Exam Review 
Questions and answers, VERIFIED/ 
Which of the following lists the three principles included in the Belmont Report? - -Respect for 
Persons, Beneficence, Justice 
Which of the following is an example of how the Principle of Beneficence can be applied to a study 
emp...
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Questions and answers, VERIFIED/ 
Which of the following lists the three principles included in the Belmont Report? - -Respect for 
Persons, Beneficence, Justice 
Which of the following is an example of how the Principle of Beneficence can be applied to a study 
emp...
SOCRA Exam Review Questions and 
answers, Verified/ 
When isn't an IND application needed? - -IND Application is not needed if investigation does not 
support change in labeling 
What information must the general IND include? 
(21 CFR 312.23) - --Form 1571- cover sheet 
-Table of contents 
-Inve...
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answers, Verified/ 
When isn't an IND application needed? - -IND Application is not needed if investigation does not 
support change in labeling 
What information must the general IND include? 
(21 CFR 312.23) - --Form 1571- cover sheet 
-Table of contents 
-Inve...
SOCRA 2 exam Review Questions and 
answers, Verified/ 
Adverse Event - -- any unfavourable/unintended change 
- no causal relationship needed 
- may occur during or after administration of the investigational product 
Adverse drug reaction (before market approval) - -unintended response related to...
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answers, Verified/ 
Adverse Event - -- any unfavourable/unintended change 
- no causal relationship needed 
- may occur during or after administration of the investigational product 
Adverse drug reaction (before market approval) - -unintended response related to...
CITI - SoCRA - GCP for Clinical Trials 
with Investigational Drugs and Biologics 
(ICH Focus), Questions and answers, 
VERIFIED/ 
Which of the following lists the three principles included in the Belmont Report? - -Respect for 
Persons, Beneficence, Justice 
Which of the following is an example ...
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Add to cartCITI - SoCRA - GCP for Clinical Trials 
with Investigational Drugs and Biologics 
(ICH Focus), Questions and answers, 
VERIFIED/ 
Which of the following lists the three principles included in the Belmont Report? - -Respect for 
Persons, Beneficence, Justice 
Which of the following is an example ...
SOCRA CCRP Exam Questions and 
answers, rated A+ 
April 30 1996 - -ICH GCP Development Date 
Quality - -ICH Q 
Efficacy - -ICH E 
Safety - -ICH S 
Multidisciplinary - -ICH M 
guidance for industry, consolidated guideance - -ICH E 6 
Clinical Safety Data Management Definitions and Standards - -ICH E...
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Add to cartSOCRA CCRP Exam Questions and 
answers, rated A+ 
April 30 1996 - -ICH GCP Development Date 
Quality - -ICH Q 
Efficacy - -ICH E 
Safety - -ICH S 
Multidisciplinary - -ICH M 
guidance for industry, consolidated guideance - -ICH E 6 
Clinical Safety Data Management Definitions and Standards - -ICH E...
SOCRA Certification Exam Questions 
and answers, rated A+/ 
Does the FDA consider electronic signatures to be as trustworthy and
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and answers, rated A+/ 
Does the FDA consider electronic signatures to be as trustworthy and
SoCRA Certification Exam Questions 
and answers, VERIFIED/ 
Biometrics - -A method of verifying an individual's identity based on measurement of the 
individual's physical features or repeatable actions where those features and or actions are both unique 
to that individual and measurable. (21 ...
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and answers, VERIFIED/ 
Biometrics - -A method of verifying an individual's identity based on measurement of the 
individual's physical features or repeatable actions where those features and or actions are both unique 
to that individual and measurable. (21 ...
CITI - SoCRA - GCP for Clinical Trials 
with Investigational Drugs and Biologics 
(ICH Focus): Questions and answers, 
Verified/ 
Which of the following lists the three principles included in the Belmont Report? - -Respect for 
Persons, Beneficence, Justice 
Which of the following is an example ...
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Add to cartCITI - SoCRA - GCP for Clinical Trials 
with Investigational Drugs and Biologics 
(ICH Focus): Questions and answers, 
Verified/ 
Which of the following lists the three principles included in the Belmont Report? - -Respect for 
Persons, Beneficence, Justice 
Which of the following is an example ...
SOCRA Practice Test Questions and 
answers, rated A+ 
Which of the following is a disclosure of financial interests form? - -FDA Form 3455 
Which of the following is a certification of financial interest form? - -FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he...
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answers, rated A+ 
Which of the following is a disclosure of financial interests form? - -FDA Form 3455 
Which of the following is a certification of financial interest form? - -FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he...
SOCRA certification: Class Quizzes 
Week 1-5. Questions and answers, 
verified/ 
The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical 
products from what three regions? -- European Union, Japan and United States 
What organizations are represented i...
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Add to cartSOCRA certification: Class Quizzes 
Week 1-5. Questions and answers, 
verified/ 
The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical 
products from what three regions? -- European Union, Japan and United States 
What organizations are represented i...
SOCRA Practice Test Questions and 
answers, rated A+ 
Which of the following is a disclosure of financial interests form? - -FDA Form 3455 
Which of the following is a certification of financial interest form? - -FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he...
Preview 2 out of 13 pages
Add to cartSOCRA Practice Test Questions and 
answers, rated A+ 
Which of the following is a disclosure of financial interests form? - -FDA Form 3455 
Which of the following is a certification of financial interest form? - -FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he...
SoCRA Certification Exam Questions 
and answers, rated A+ 
Biometrics - -A method of verifying an individual's identity based on measurement of the 
individual's physical features or repeatable actions where those features and or actions are both unique 
to that individual and measurable. (21 C...
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Add to cartSoCRA Certification Exam Questions 
and answers, rated A+ 
Biometrics - -A method of verifying an individual's identity based on measurement of the 
individual's physical features or repeatable actions where those features and or actions are both unique 
to that individual and measurable. (21 C...
SOCRA Practice Test Questions and 
answers, rated A+ 
Which of the following is a disclosure of financial interests form? - -FDA Form 3455 
Which of the following is a certification of financial interest form? - -FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he...
Preview 2 out of 13 pages
Add to cartSOCRA Practice Test Questions and 
answers, rated A+ 
Which of the following is a disclosure of financial interests form? - -FDA Form 3455 
Which of the following is a certification of financial interest form? - -FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he...
SOCRA Exam Questions & Answers, 
rated A+. 
Electronic signature are currently accepted for any and all records, paper or electronic form. True or 
False? - -False. The general provisions for electeonic signature criteria apply to records that are 
i. Created, modified, maintained, archived, retr...
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rated A+. 
Electronic signature are currently accepted for any and all records, paper or electronic form. True or 
False? - -False. The general provisions for electeonic signature criteria apply to records that are 
i. Created, modified, maintained, archived, retr...
SOCRA CCRP Exam Questions and 
answers, rated A+ 
April 30 1996 - -ICH GCP Development Date 
Quality - -ICH Q 
Efficacy - -ICH E 
Safety - -ICH S 
Multidisciplinary - -ICH M 
guidance for industry, consolidated guideance - -ICH E 6 
Clinical Safety Data Management Definitions and Standards - -ICH E...
Preview 3 out of 24 pages
Add to cartSOCRA CCRP Exam Questions and 
answers, rated A+ 
April 30 1996 - -ICH GCP Development Date 
Quality - -ICH Q 
Efficacy - -ICH E 
Safety - -ICH S 
Multidisciplinary - -ICH M 
guidance for industry, consolidated guideance - -ICH E 6 
Clinical Safety Data Management Definitions and Standards - -ICH E...
SOCRA Exam Review Questions and 
answers, rated A+ 
When isn't an IND application needed? - -IND Application is not needed if investigation does not 
support change in labeling. 
What information must the general IND include? 
(21 CFR Part 312.23) - --FDA Form 1571 
-FDA Form 1571 cover sheet 
-...
Preview 3 out of 24 pages
Add to cartSOCRA Exam Review Questions and 
answers, rated A+ 
When isn't an IND application needed? - -IND Application is not needed if investigation does not 
support change in labeling. 
What information must the general IND include? 
(21 CFR Part 312.23) - --FDA Form 1571 
-FDA Form 1571 cover sheet 
-...
Socra CCRP, Questions and answers, 
Verified/ 
Contract Research Organization - -A person or an organization (commercial, academic, or other) 
contracted by the sponsor to 
perform one or more of a sponsor's trial-related duties and functions. 
When a short form is used for informed consent the w...
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Verified/ 
Contract Research Organization - -A person or an organization (commercial, academic, or other) 
contracted by the sponsor to 
perform one or more of a sponsor's trial-related duties and functions. 
When a short form is used for informed consent the w...
SoCRA Study Guide: Review Questions 
and answers. VERIFIED/ 
IRB approval - -the determination of the IRB that the clinical investigation has been reviewed and 
may be conducted at an institution within the constraints set forth by the IRB and other institutional and 
federal requirements. 
Contr...
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and answers. VERIFIED/ 
IRB approval - -the determination of the IRB that the clinical investigation has been reviewed and 
may be conducted at an institution within the constraints set forth by the IRB and other institutional and 
federal requirements. 
Contr...
SoCRA Exam Review Questions and 
answers, VERIFIED/ 
What is an orphan drug program? - -FDA program that provides development of drugs for rare 
diseases 
Nuremburg Code - -set of standards proclaimed following the trial of Nazi doctors in 1947 
Kefauver-Harris Amendment - -Amendment to Food Drug ...
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answers, VERIFIED/ 
What is an orphan drug program? - -FDA program that provides development of drugs for rare 
diseases 
Nuremburg Code - -set of standards proclaimed following the trial of Nazi doctors in 1947 
Kefauver-Harris Amendment - -Amendment to Food Drug ...
SOCRA CCRP Exam Review Questions 
and answers, VERIFIED/ 
Timeline of Historical Events - -Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont 
Report 1979 
The Three Principles of the Belmont Report - -respect for persons, beneficence, justice 
Application of Respect for Persons - -informe...
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and answers, VERIFIED/ 
Timeline of Historical Events - -Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont 
Report 1979 
The Three Principles of the Belmont Report - -respect for persons, beneficence, justice 
Application of Respect for Persons - -informe...
SOCRA CCRP Exam Practice Questions 
and answers, VERIFIED/ 
21 CFR part 11 regulates? - -Electronic Signatures 
What is the name of FDA Form 483? - -Inspectional Observation 
What does 21CFR56 regulate? - -Institutional Review Boards 
An application for Investigational Device Exemption is part of 2...
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and answers, VERIFIED/ 
21 CFR part 11 regulates? - -Electronic Signatures 
What is the name of FDA Form 483? - -Inspectional Observation 
What does 21CFR56 regulate? - -Institutional Review Boards 
An application for Investigational Device Exemption is part of 2...
SOCRA CCRP Exam Review questions 
and answers, VERIFIED/ 
April 30 1996 - -ICH GCP Development Date 
Quality - -ICH Q 
Efficacy - -ICH E 
Safety - -ICH S 
Multidisciplinary - -ICH M 
guidance for industry, consolidated guideance - -ICH E 6 
Clinical Safety Data Management Definitions and Standards ...
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Add to cartSOCRA CCRP Exam Review questions 
and answers, VERIFIED/ 
April 30 1996 - -ICH GCP Development Date 
Quality - -ICH Q 
Efficacy - -ICH E 
Safety - -ICH S 
Multidisciplinary - -ICH M 
guidance for industry, consolidated guideance - -ICH E 6 
Clinical Safety Data Management Definitions and Standards ...
SOCRA CCRP, Exam Review Questions 
and answers, rated A+ 
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, fede...
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and answers, rated A+ 
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, fede...
SOCRA CCRP Exam Review Questions 
and answers, rated A+ 
FDA Part 11 - -electronic signatures are of the same validity as handwritten signatures, must 
provide 2 identifiers and verify identification of signer 
FDA Part 50 - -Food and Drugs, and ICF 
FDA Part 56 - -IRBs 
FDA Part 312 - -investigat...
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and answers, rated A+ 
FDA Part 11 - -electronic signatures are of the same validity as handwritten signatures, must 
provide 2 identifiers and verify identification of signer 
FDA Part 50 - -Food and Drugs, and ICF 
FDA Part 56 - -IRBs 
FDA Part 312 - -investigat...
SOCRA EXAM Review Questions and 
answers, rated A+ 
EIR - -Establishment Inspection Report 
21 CFR Part 11 - -Electronic records & electronic signatures 
21 CFR Part 50 - -Protection of human subjects; general requirements of ICF; ICF if patient is in 
coma, life threatening conditions 
21 CFR Par...
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answers, rated A+ 
EIR - -Establishment Inspection Report 
21 CFR Part 11 - -Electronic records & electronic signatures 
21 CFR Part 50 - -Protection of human subjects; general requirements of ICF; ICF if patient is in 
coma, life threatening conditions 
21 CFR Par...
CCRP SOCRA Exam - Practice Exam #1: 
Exam Review Questions and answers, 
VERIFIED/ 
The responsibility for ensuring that the investigator understands a clinical trial lies with which 
individual/or organization? 
A) FDA 
B) IRB 
C) Sponsor 
D) Coordinator 
C) Sponsor 
What is the minimum number o...
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Add to cartCCRP SOCRA Exam - Practice Exam #1: 
Exam Review Questions and answers, 
VERIFIED/ 
The responsibility for ensuring that the investigator understands a clinical trial lies with which 
individual/or organization? 
A) FDA 
B) IRB 
C) Sponsor 
D) Coordinator 
C) Sponsor 
What is the minimum number o...
SOCRA Exam Review Questions and 
answers, rated A+ 
What is the minimum number of Institutional Review board (IRB) members? - -5 
The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new 
dosage would be? - -77 
The responsibility for ensuring that the inv...
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answers, rated A+ 
What is the minimum number of Institutional Review board (IRB) members? - -5 
The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new 
dosage would be? - -77 
The responsibility for ensuring that the inv...
SoCRA Exam Review Questions and 
answers, rated A+ 
45 CFR 46 Subpart A - -"Basic HHS Policy for Protection of Human Research Subjects": (46.100) 
Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and 
documenting informed consent, 3) Institutional Revi...
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answers, rated A+ 
45 CFR 46 Subpart A - -"Basic HHS Policy for Protection of Human Research Subjects": (46.100) 
Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and 
documenting informed consent, 3) Institutional Revi...
SOCRA CCRP Certification Exam Review 
Questions and answers/ verified. 
Nuremburg Code - -The first set of principles outlining professional ethics for clinical research. 
Nuremburg Code elements - -1. Voluntary informed consent 
2. research benefits society 
3. should be based on prior animal work...
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Questions and answers/ verified. 
Nuremburg Code - -The first set of principles outlining professional ethics for clinical research. 
Nuremburg Code elements - -1. Voluntary informed consent 
2. research benefits society 
3. should be based on prior animal work...
SOCRA (CCRP) Exam Practice 
Questions & Answers, rated A+ 
The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, 
that individuals should be treated as autonomous agents, and second, that: - -Persons with 
diminished autonomy are entitled to ...
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Questions & Answers, rated A+ 
The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, 
that individuals should be treated as autonomous agents, and second, that: - -Persons with 
diminished autonomy are entitled to ...
MEGA SOCRA CCRP EXAM CONTENT. 
Questions and answers, VERIFIED/ 
5 
The minimum number of IRB members 
Subjects cannot be enrolled until IRB/IEC approval has been obtained 
In a non-emergency situation, under which of the following conditions, if any, may subjects be 
enrolled into a study prior t...
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Questions and answers, VERIFIED/ 
5 
The minimum number of IRB members 
Subjects cannot be enrolled until IRB/IEC approval has been obtained 
In a non-emergency situation, under which of the following conditions, if any, may subjects be 
enrolled into a study prior t...
SOCRA Exam Review Questions and 
answers, VERIFIED/ 
Electronic Records - -Use of electronic records must have procedures to ensure the authenticity, 
integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily 
repudiate the signed records a snot genuine ...
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answers, VERIFIED/ 
Electronic Records - -Use of electronic records must have procedures to ensure the authenticity, 
integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily 
repudiate the signed records a snot genuine ...
SOCRA FDA Exam review Questions and 
answers, Verified/ 
If immediate use of the test article (exception) is used to preserve the life of a subject and time is not 
sufficient to obtain IC, within X an independent physician should review the use of the article - -5 
days 
If an article is used in...
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answers, Verified/ 
If immediate use of the test article (exception) is used to preserve the life of a subject and time is not 
sufficient to obtain IC, within X an independent physician should review the use of the article - -5 
days 
If an article is used in...
SOCRA Practice 1 Exam Review 
Questions and answers, rated A+ 
True or False 
The terms "treatment protocol" and "treatment IND" are interchangeable and mean the same thing. 
False. A treatment protocol is sponsored by a sponsor, while a treatment IND (Investigational New Drug) 
is sponsored b...
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Questions and answers, rated A+ 
True or False 
The terms "treatment protocol" and "treatment IND" are interchangeable and mean the same thing. 
False. A treatment protocol is sponsored by a sponsor, while a treatment IND (Investigational New Drug) 
is sponsored b...
SOCRA certification: Class Questions 
and answers, Week 1-5. VERIFIED/ 
The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical 
products from what three regions? - -European Union, Japan and United States 
What organizations are represented in the ICH ...
Preview 2 out of 11 pages
Add to cartSOCRA certification: Class Questions 
and answers, Week 1-5. VERIFIED/ 
The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical 
products from what three regions? - -European Union, Japan and United States 
What organizations are represented in the ICH ...
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