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Instructions: A source data location list (SDLL) defines the source for all data items recorded in the e/pCRF, & it should ensure that source documents for all data items captured in the e/pCRF.

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Related content

Good documentation practice in clinical research...
by C Bargaje · 2011 · Cited by 47 — Source data are contained in source documents...
Learn more
Electronic Source Data in Clinical Investigations...
source data in FDA-regulated clinical investigations. ... A list of all authorized data...
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Study Data Technical Conformance Guide - US Food...
Section 5: Therapeutic Area Standards – presents supplemental considerations and...
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Related links form

Standard Insurance Company SI 17985 2018 DC Standard Insurance Company SI 17985-DC 2017 Boston Scientific MH-394728-AH 2019 UT Davis School District Student Information Questionnaire McKinney-Vento Eligibility 2020

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Ethics. ... Trial risk vs trial benefit. ... Information on the Medicinal Product. ... Compliance with the study protocol. ... Medical decisions. ... Informed consent. ... Confidentiality. ... Good Manufacturing Practice.

Source data are contained in source documents (original or certified). A Case Report Form (CRF) is a printed or electronic document designed to record all of the study data about a study participant. For all projects, data is reported to the study sponsor.

GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial.

An eCRF (electronic case report form) is a digital questionnaire that is used to collect data about a clinical study and research participants. The data collected in eCRFs is what biostatisticians analyze to draw a conclusion from a study.

Source Documents: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being ...

GCP addresses elements related to the design, conduct and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data) of clinical trials. The study's Principal Investigator is responsible for identifying staff that are required to take GCP training.

Three principles of equal importance associated with basic ethics, particularly recognized for persons, beneficence, and justice, permeate all other GCP principles.

GCP - 13 Principles Clinical trials should be conducted in ance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232