「原資料」に求められるもの ALCOAの原則

1 *) CSL *)2011 11 Japan 2011 11 Agenda ALCOA CCEA 2011 11 Global ? Global Global 2011 11 C Investigator ICH-GCP ) CRF ICH-GCP )

2 FDA/EMA Inspection 2011 11 Attributable, Contemporaneous, Original, Consistent Original Contemporaneous Legible / Attributable / FDAFDA ALCOA ALCOA EMAEMA ALCOA(CCEA) ALCOA(CCEA) Complete Consistent Enduring Available when needed EMA/INS/GCP/454280/2010 GCP Inspectors Working Group (GCP IWG) Guidance for Industry computerized Systems used in clinical Investigations, May 2007(FDA) Accurate ALCOA CCEA 2011 11 ALCOA CCEA FDA EMA Guidance for Industry computerized Systems used in clinical Investigations, May 2007(FDA) -Such electronic source data and source documentation must meet the same fundamental elements of data quality ( , attributable, legible, contemporaneous, original and accurate)

3 That are expected of paper records and must comply with all applicable statutory and regulatory requirements Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials, Jun 2010(GCP Inspectors Working Group/EMA) - Source data should be Accurate, Legible, Contemporaneous, Original, Attributable, Complete and Consistent. (Requirement 2, ICH GCP , , and ) - A number of attributes are considered of universal importance to source data and the records that hold those data.

4 These include that the data and records are: Accurate, Legible, Contemporaneous, Original, Attributable, Complete, Consistent, Enduring, Available when needed 2011 11 ( 23 6 30 0630 1 ) 4-3-4 . - ALCOA CRC LDM : FDA Food and Drug Administration Accurate Legible Contemporaneous Original Attributable ALCOA CCEA 2011 11 Attributable / 125/80 130/85 TN 130/85 TN 02 Mar 2011(02 Mar 2011())

5 15 9 12 0912001 18 10 2011 11 Contemporaneous / 2011 11 Original (1/3 * ICH-GCP Original GCP *.)

6 2011 11 ICH GCP Source Document Glossary ICH-GCP Original documents, data, and records ( , hospital records, clinical and office charts, laboratory notes, memoranda, subjects diaries or evaluation checklists, pharmacy dispending records, recorded data from automated instruments, copies, and records kept at the pharmacy , at the laboratories and the clinical trial Original (2/3) Source Data: Also known as original data, those values that represent the first recording of clinical trial data elements.)

7 (Draft Guidance for Industry: Electronic Source Documentation in clinical Investigations, Dec 2010)Source Data: Also known as original data, those values that represent the first recording of clinical trial data elements. (Draft Guidance for Industry: Electronic Source Documentation in clinical Investigations, Dec 2010) 2011 11 Original (3/3) 3. - - - - - 1. - 2.

8 - - - - 2011 11 Consistent , 2 1 1 2011 11 ALCOA CCEA ( 23 6 30 0630 1 ) 4-3-4.

9 2011 11 ( certified copy Legible / Legible / Enduring Enduring Available when needed Available when needed 2011 11 - - - - / 2011 11)

10 CRC 2011 11