Week 5

Question 1

Source Document

Answer 1

A source document is classified as any document containing data that was directly communicated by or taken from an enrolled subject

Question 2

Action items at an IMV

Answer 2

• sign the site visit log
• review and verify source
• patient eligibility
• IP accountability
• regulatory updates
• Protocol compliance
• complete action items from previous visits

Question 3

Source Date Verification

Answer 3

SDV
- the aim of SDV is to perform an empirical evaluation of the Source document in comparison to the CRFs for the site to ensure data congruency

Question 4

ALCOA-C

Answer 4

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate
• Complete

Question 5

Attributable

Answer 5

(Who is responsible?)

• Who documented the data?
• If a change is made to a document, who made the change?

Question 6

Legible

Answer 6

• Cross check signatures to make sure signatures have not been forged

Question 7

Contemporaneous

Answer 7

• Results should be recorded as they are observed and signatures should be accompanied by a date to document chronology
• If a clinical observation cannot be documented at the time of the observation, the delay should be defined and justified

Question 8

Original

Answer 8

• Study record should be original and not a photocopy
• If a copy is made, it should be exact and attributed to who made the copy. The investigator should always keep the original source document

Question 9

Accurate

Answer 9

• The document and data should be accurate, real, and represent the facts. There should be a high level of honesty and accuracy in reporting, and documents should be double checked for accuracy

Question 10

Complete

Answer 10

• Is the document complete?

- Is the log complete up to the current date?

Question 11

SDV vs SDR

Answer 11

• The aim of Source Data Verification is to perform an empirical evaluation of the Source Document in comparison to the CRFs for the site to ensure data congruency

Question 12

Source Data Review

Answer 12

• SDR is not a comparison of source data against CRF data, but rather, a review of source documentation to check quality of source, review protocol compliance, and ensure critical processes and source documentation are adequate

Question 13

IP Accountability

Answer 13

4 verifications
IP Acc is the process of:
- Accounting for all shipped IP
- Accounting for all dispensed IP
- Drug destruction
- Storage compliance

Question 14

In general, how to handle a protocol deviation

Answer 14

1. Query the site for more information in order to confirm the deviation
2. Inform the site in writing(email on EDC)
3. Inform your study team, Document as an observation on your MVR and/or CTMS
4. Re-train site staff on proper study procedure according to protocol(can be done via email)
5. Report to the IRB (if Necessary)

Question 15

Verification 1

Answer 15

• Is the amount of IP the sponsor sent to the site accounted for?
• Request IP delivery receipts and shipment log (usually stored in pharmacy)

Question 16

Verification 2

Answer 16

• Did drug maintain the required temperature ranges in transit to the site?
• Refer to the protocol to determine temperature range for the IP
• Refer to the temperature tracking device for temperature data

Question 17

Verification 3

Answer 17

• Is the IP held in a secured double locked environment and maintaining protocol specified temperature ranges?

Question 18

Verification 4

Answer 18

Is the amount of IP issued from the site to enrolled subjects accounted for?

• Request IP dispensation log (usually stored in pharmacy)
• Compare IXRS to IP dispensation log for data accuracy
• Manually count pills in returned containers for data accuracy