How should you correct an error in a case report form?
Any errors on the CRF should be corrected by drawing a single line through the incorrect value/text so that it is still legible.
Who may endorse entries and corrections in the case report form CRF )?
Sponsors should have written procedures to assure that changes or corrections in CRFs made by sponsor’s designated representatives are documented, are necessary, and are endorsed by the investigator. The investigator should retain records of the changes and corrections. 5.18.
What does Alcoa C stand for?
The Food and Drug Administration (FDA) first introduced the “ALCOA” concept, Attributable, Legible, Contemporaneous, Original, and Accurate, as the fundamental principles of data quality that research documentation must meet.
Do case report forms need IRB approval?
Yes. Under HIPAA, a case report is an activity to develop information to be shared for medical/educational purposes. Although the use of protected health information to prepare the paper does not require IRB review, the author of a case report must comply with HIPAA.
Which statement about changes or corrections to a CRF is correct?
Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (i.e., an audit trial should be maintained); this applies to both written and electronic changes or corrections (see section 5.18.
Which of the following are GCP responsibilities of the investigator?
What is GCP?
- Ensures that the rights, safety, and well-being of study participants are protected.
- Ensures the integrity of the data submitted for approval.
- Sets standards for a system of mutual accountability among sponsors, regulatory authorities, investigators, and IRBs.
What types of documents should meet Alcoa C criteria?
ALCOA + C to achieve data quality:
- Attributable. It should be obvious who documented or did what; traceable to a person, date, and subject visit.
- Legible. The Record should be easy to read and signatures identifiable (if not then print name also).
- Contemporaneous.
- Original.
- Accurate.
- Complete.
What is the cornerstone of ICH GCP?
Data Integrity and System Validation The new guidance identifies data integrity as a cornerstone of GCP, and states that trial data systems must ensure data integrity, particularly with regard to technology changes and software updates.
What are the principles of good clinical practice?
– appropriate qualifications; – training and experience in the field of the proposed study; and – respected for ethical quality and professional integrity.
What are good clinical practice guidelines?
Good Clinical Practice: Consolidated Guideline and is organized as a reference and educational tool to facilitate understanding and imple-mentation of GCP by: •describing the clinical research process as it relates to health and medical products, and identifying and explaining each of the activi-
How to implement good documentation practices?
– You will be using your code in 6 months – You want people to use your code and give you credit – You want to learn self-determination – Others would be encouraged to contribute to your code
What is error checking and correction?
Automatic repeat request (ARQ) Automatic Repeat reQuest (ARQ) is an error control method for data transmission that makes use of error-detection codes,acknowledgment and/or negative acknowledgment messages,and timeouts to