A-Z Guidance

A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z 

A
Acknowledgement of Unregulated Research Activities Activities Not Under the Pitt IRB Jurisdiction Advertisements Adverse Events Log Audit by Federal Agency
B
Belmont Report Blood Drawings for Human Subject Research
C
Certificate of Confidentiality NIH Kiosk Children in Research Child Clearances Children's Online Privacy Protection Act (COPPA) CITI Training ClinicalTrials.gov Code of Federal Regulations [21 CFR 56]  Cohort Discovery Common Rule [45 CFR 46] Common Rule 2018 Continuing Review - OHRP Guidance	Coordinating Center Applications and Responsibilities Application for Coordinating Center COVID-19 (Coronavirus) Consent Guidance Guidance/Suggested Wording Child Research Signature Lines Consent Forms in Medical Records Family Members Information Key Information Low Literacy and Disabled Participants Not Reasonably Available Reconsent Short Form Consent Forms UPMC Cost Language
Data Security Assessment Form Tip Sheet for Completing Assessment Form Data Security Guidance Data Security-Pitt Information Technology Data and Safety Monitoring Plan Data and Safety Monitoring Board/Committee Data Management-University Guidelines Data Use Agreement (DUA)	Decedent Research Decisional Impairment Checklist Declaration of Helsinki Department of Defense Checklist Device (PittPRO) Drug Evaluation and Research - FDA Guidance Drug (PittPRO) IND Determination
E
Electronic Signatures Emergency Use (EU) EU Consent Template EU Drug or Biologic EU Medical Device Engagement of Institutions in Human Subjects Research Exempt Review (2018 Revised Rule)	Expedited Review External Pathway
F
Faculty Mentor Responsibilities FDA: Medical Devices FDA: Medical Apps FDA: Drugs FDA: Good Clinical Practice FDA: Guidance for IRBs, Clinical Investigators, and Sponsors FDA: Decisions for Investigational Device Exemption Clinical Investigations (issued 8.19.2014) FDA: MedWatch	Family Educational Rights and Privacy Act (FERPA) Federal Wide Assurance -DHHS Federal Wide Assurance (FWA) and Engaged in Research  Finder's Fees and Payments to Research and Clinical Staff
G
Genetic Information Nondiscrimination Act (GINA) Genomic Repository Guidance (dbGaP/Other NIH-designated) GDPR (European Union General Data Protection Regulation)
H
HIPAA HIPAA Checklist HIPAA Checklist: Example Language HIPAA Authorization and Decedent Research HIPAA Privacy Rule - Databases and Research Repositories - NIH Guidance HIPAA Privacy Rule Information for IRBs - NIH Guidance HIPAA Privacy Rule Information for Researchers - NIH Guidance	Honest Broker Honest Broker Assurance Form
Industry-Sponsored Fee Information Fee Form Innovative Practice Institutional Review Boards-FDA [21 CFR Part 56] Internet and Human Subject Research - DHHS International Compilation of Human Research Standards International Research Introductory Script Sample
J
K
Key Information in Consent Form
L
Leaving the University Checklist Log for Adverse Events Log for Noncompliance / Deviations
M
Material Transfer Agreements (MTA) Memo of Cultural Appropriateness Mobile Medical Device-FDA Mobile App-IRB Review	Modifications
N
Non-English Speaking Participants Noncompliance/Deviation Log
O
Off-Label Drugs and Biologics OSIRIS (IRB application system)
P
Paper Submission Forms Payment Procedure for Human Subjects - Vincent PittPRO Information Drug Section IND Determination Device Section Protection of Pupil Rights Amendment (PPRA)	Prisoners: OHRP Guidance on the Involvement of Prisoners in Research Privacy and Confidentiality for Research Participants Protection of Human Subjects (FDA) 21 CFR 50
Q
Quality Improvement Activities FAQ - OHRP
R
Radiation Guidance Reliance Guidance Individual Investigator Agreement (IIA) IRB Fee Sheet Overview of Reliance Request System Content Pitt Cede IRB Review Pitt IRB of Record	Reportable New Information Reportable New Information FAQs Log for Adverse Events Log for Noncompliance / Deviations
S
Short Form Consent Documents Site Permission Letter Student Researchers Study Status
T
Telephone Screening Script Tip Sheet for OSIRIS Conversions Transition of Data Analysis Only and Long Term Follow Up to PittPRO Translator Certification Form
U
UPMC Fiscal Form
V
Visitors on Campus (Academic and Research)
W
X
Y
Z