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Get Source Data Location List

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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How to fill out the Source Data Location List online

The Source Data Location List is a vital document in managing data for clinical studies. It is essential for clearly identifying the sources of all data items recorded in the electronic or paper case report forms, ensuring easy access and accuracy of collected data.

Follow the steps to complete the Source Data Location List online.

  1. Press the ‘Get Form’ button to retrieve the Source Data Location List and open it in your preferred online editing tool.
  2. Begin filling in the header section by inserting the study title and acronym. Ensure that this is accurately stated as it is crucial for documentation.
  3. Designate the study site and provide the name of the local principal investigator responsible for overseeing the data collection at this site.
  4. For each data item, identify the source by specifying the type of source data and its location. Be precise, for example, differentiate between electronic patient files, paper files, or worksheets.
  5. Document the current version and date of the Source Data Location List to maintain organizational standards and ensure compliance.
  6. At the bottom of the form, include the date of signature, and ensure that the local principal investigator or their delegate signs the document to confirm responsibility for its accuracy.
  7. Once all fields are completed, save your changes. You can also download or print the form for your records and share it as needed.

Complete your documents online to ensure efficient management and compliance.

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Good documentation practice in clinical research...
by C Bargaje · 2011 · Cited by 47 — Source data are contained in source documents...
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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
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Help Portal
Legal Resources
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
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 WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
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