�ݺ�ߣ

Editor's Notes

1. What is a Source Document? ICH guidelines define source data as “all information in original records and certified copies of original records of clinical findings, observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents. ICH guidelines goes on to define source documents as “original documents, data, and records . Perhaps a clearer definition of a source document would be: The first place any study-related information is recorded, whether by hand or electronically. Source Documentation
2. Examples of Source Documents Hospital records Clinical and office charts Laboratory reports Participant diaries Pharmacy dispensing records Data recorded from automated instruments Surgical reports X-rays Electronic records, if data are entered directly into the computer system and not written down first anywhere else Case report forms, only if data are first noted on these (.e. there is no prior written or electronic record of the data). ICH guidelines state that if sections of the CRF are to be considered source documents, these sections should be identified in the protocol. Source Documentation
3. ICH E6: “The identification of any data to be recorded on the CRF (i.e. no prior written record of data), and considered to be source data” must be identified in the protocol Maintain list of CRFs to be used at site 1. to ensure consistency at the site 2. the site needs to clearly indicate at the start of the monitoring visit which CRFs are being used as source documents If a site uses a CRF as source documentation, it should be used consistently as source documentation during the trial for all subjects at the site. As a source document, the original CRF must be signed/initialed and dated by the individual recording the data on the CRF so that there is a clear audit trail of who completed the documentation CRFs used as source docs must be maintained and made available for review in the same manner as other source docs CRFs used as source doc- site should retain original CRF at site Clinicians use physical examination CRF pages to record PE findings instead of documenting their findings to a source document first.
4. ICH E6: “The identification of any data to be recorded on the CRF (i.e. no prior written record of data), and considered to be source data” must be identified in the protocol Maintain list of CRFs to be used at site 1. to ensure consistency at the site 2. the site needs to clearly indicate at the start of the monitoring visit which CRFs are being used as source documents If a site uses a CRF as source documentation, it should be used consistently as source documentation during the trial for all subjects at the site. As a source document, the original CRF must be signed/initialed and dated by the individual recording the data on the CRF so that there is a clear audit trail of who completed the documentation CRFs used as source docs must be maintained and made available for review in the same manner as other source docs CRFs used as source doc- site should retain original CRF at site Clinicians use physical examination CRF pages to record PE findings instead of documenting their findings to a source document first.
5. Certified copies of source docs are considered to be as valid as original source docs provided they are certified. The verification process employed to certify copies of source docs should be documented in a standard operating procedure. Certified copy must be signed and dated by the person who ensured the integrity of the process plus a certification statement (that the copy is an exact copy of the original having all the same attributes and information as the original). If the original document is retained elsewhere, the copy does not need to be certified (e.g. original lab results are filed in the lab) Certification of copies received from an outside institution indicates that it is an unaltered copy as received Documents received via fax are copies NOT originals An example of where a certified copy of a source document might be necessary: most commonly when the original documents are unavailable due to litigation proceedings or less commonly when the original records are transported from one healthcare facility to another.
6. Documentation of source data is necessary for the reconstruction, evaluation, and validation of clinical findings, observations and other activities during a trial. Source documentation serves to substantiate the integrity of trial data, confirm observations that are recorded, and confirm the existence of subjects. This standard also serves to ensure data quality by creating audit trails and enabling verification that data are present, complete and accurate. The golden rule in GCP is that the information entered into CRFs must match the source documentation, data point to data point. Source documentation is the starting point for a verifiable audit trail. According to ICH GCP guidelines, monitors are required to verify that “source data/documents and other trial records are accurate, complete, up-to-date and maintained”. They are also required to check the accuracy and completeness of CRF entries and source documentation against each other. Source Documentation
7. Given the importance of raw data as the original record, can corrections be made to the source data? Yes, provided that the original values are not obscured. No whiteout, redactions are any other means to obliterate the data is acceptable. One line through, write new data, initial, date and explain (if necessary). When raw text must be inserted, it cannot be squeezed between the lines or in the margins. It should be documented as a signed addendum, and a separate, new and dated page that includes the additions should be added directly after the page to be amended. Never use pencil Never destroy original documents if they require error correction Addenda must be made by the research clinician responsible for the subject Source Documentation