The Raw Data May Be Traced Back to The Source Essay

As we discussed in this module, the study needs to tell a story, and a lot goes into study storytelling.  After reading the module web-pages, answer the following questions.  Each question should be more than a few words, and reflect what you learned in this module as well as apply what you have learned in previous CRC courses.

• Describe each component of ALCOA-C.
• Describe steps taken during documentation audits.  How should one correct a written mistake, and who should make the correction?
• Select one of the FDA citations (table 4) from the Clinical Researcher article.  To the best of your ability describe how a mistake such as this can occur?  What steps would you take (beyond the listed prevention strategies) would you take to ensure this doesn’t happen to you?

4.Describe the elements of an effective source documents.  What are some elements of a poorly designed source document?

Table 4: FDA Citations Using the Code of Federal Regulations and Examples

FDA Citation
21 CFR 312.60: Failure to ensure that the investigation was conducted according to the investigational plan.

Violation Examples

1. Enrolling ineligible subjects not meeting study entry criteria.
2. Missing study procedures indicated in the protocol, such as chest X-rays or electrocardiograms.

3. Disqualifications during study run-in period, yet patient enrolled.

Prevention Strategies

1. Have a colleague double-check study entry criteria before a patient is enrolled.
2. If using an EMR, capitalize on tools to help you find information quickly.

3. Cross reference protocol with Schedule of Events to make sure procedure milestones are met.

FDA Citation

21 CFR 312.62(a): Failure to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects.

Violation Examples

1. Drug dispensed does not match the amount taken by the research participant.

2. The amount of drug returned does not match what should have been returned.

Prevention Strategies

1. Count and document drug return with the subject present, not after the person has left.
2. Count medication before dispensing.

3. Discrepancies should be explained in source or note to file.

FDA Citation

21 CFR 312.62(b): Failure to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.

Violation Examples

1. Absence of accurate histories documented.

2. Failure to complete forms required.

Prevention Strategies

1. Keep medical history section updated.
2. Use source documents that have been verified by sponsor or CRO.

FDA Citation

21 CFR 312.62 (c ): Failure to retain records required to be maintained under 21 CFR Part 312 for a period of two years following the date a marketing application is approved for the drug for the indication for which the drug is being investigated; or, if no application is filed or if the application is not approved for such indication, until two years after the investigation is discontinued.

Violation Examples

1. Not maintaining records related to drug disposition, including dates, quantities, and usage.
2. Not retaining consent forms and case report forms.

Prevention Strategies

1. Keep a drug dispensation log with study drug accountability.
2. Check with sponsor prior to shredding documents.

3. If possible, scan informed consents into the electronic medical record.