This is a checklist that can be used to review investigator responsibilities pertinent to data and document management in accordance with Good Clinical Practice (GCP) Guidance.
A plain language handbook for researchers illustrating why health literacy is important and how to improve the readability of consent forms and other participant materials.
- Plain language principles and strategies
- Quick reference guide and editing checklist
- Plain language alternatives to complex terms
- Easy-to-read template language for consent forms and HIPAA authorizations
- Links to helpful readability resources
This is an excerpt from the AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research. This section provides some tips to teach potential subjects about research protocols and confirm their comprehension.
More information on the toolkit can be found here:
The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research. September 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/funding/policies/informedconsent/index.html
GCP and Responsibilities of the PI and Research Team (NIH Videocast)
- Speaker: Susan D. Thompson, M.D., Medical Officer/GCP2, DSI, CDER, FDA, October 28, 2010
- Topics Covered: Overview of BIMO; DSI’s Role & Authority in BIMO Program; GCP Guidance vs. Regulations; the Clinical Investigator Role & Responsibility; Selection & Auditing CI Sites; Consequences; Sponsors
- Some key points:
- FDA/CDER GCP Regulations
- FDA has regulations governing the approval, conduct, review, and reporting of clinical research intended for submission.
- These are legally enforceable requirements.
- Inspections apply to: FDA regulated clinical and non-clinical research
- Regulatory oversight: IRB, sponsors, CROs/monitors, clinical investigators
- Relevant Regulations: 21 CFR Part 50, Part 54, Part 56, Part 312, Part 314
- FDA expectations of Clinical Investigators:
- Adherence to Code of Federal Regulations
- Knowledge of Clinical Investigator regulations
- Understanding of Clinical Investigator responsibilities
- FDA requires a statement of investigator/form 1572
- General Clinical Investigator Responsibilities
- Ensuring an investigation is conducted according to the signed investigator statement/1572, investigational plan, and applicable regulations
- Control of drugs under investigation
- Ensuring informed consent is adequately obtained according to 21 CFR 50
- Ensuring IRB review, approval, & reporting requirements are met according to 21 CFR 56
Useful Website for Study Visit calculations
Reminder this month to check all automated equipment, e.g., BP and EKG machines, for an update to Daylight Saving Time. This will help ensure your readouts are an accurate addition to your source documentation.
The FDA expects that data acquired during a clinical study follow the acronym ALCOA. Clinical trial data is required to be:
- Attributable -The record shows clearly who completed it. This confirms appropriate delegation.
- Legible -Illegible handwriting makes it difficult to re-create events recorded during the study.
- Contemporaneous -Enter study data at the time the activity is performed.
- Original -You may have recorded original data on a napkin. Keep the napkin with study record.
- Accurate -"minimize transcription" is a tip to reduce inaccurate data.
Follow the ALCOA recommendation and you are on your way to having data with integrity!
Data Collection: Correcting mistakes
- Never use correction fluid
- Never scribble out an entry
- Never erase or obscure an original entry
- Do draw one horizontal line through the error. Insert correct data next to original.
- Do Initial and date the change(never past date or future date-always use today's date)
- Do explain change (e.g., transcription error)
This ensures an audit trail exists for all data. (GCP ICH E6 4.9.3)
The goal is accurate and valid data!
Did you know?...
The FDA Good Clinical Practices Program allows you to submit GCP questions:
FDA posts replies to e-mail messages submitted to the Good Clinical Practices Program: Replies to Inquiries to FDA on Good Clinical Practice
Calculating Study Drug Compliance:
(Total dispensed - returned) / (Days between visits x dose[# of pills])
= What was taken / What should've been taken
x 100 = % Compliance
Subject comes in for study visit. You dispense 200 pills at this visit. When they return to clinic their study drug bottle has 120 remaining (returned). They were instructed to take a dose of 3 pills daily. There were 31 days between visits.
(200-120) / (31 x 3)
= 80 / 93
= 0.86 x 100 = 86% compliance
Tip: Study drug accountability includes an interview to determine if the subject took the medication, lost some of the pills, or set aside pills in a pillbox. These determinations will affect your compliance calculations.