Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site monitors are appointed by the study sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. At a minimum, source documents include the following information for each subject: • Subject identification (name, sex, race/ethnicity) • Documentation of subject eligibility • Date of informed consent • Dates of visits • Documentation that protocol specific procedures were performed • Results of study parameters, as required by the protocol • IP accountability records • Documentation of AEs and other safety parameters (if applicable) • Records regarding medical histories and the use of concomitant therapies prior to and during the study • Date of study completion and reason for early discontinuation, if applicable It is required that the author of an entry in the source documents be identifiable. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the CRF are consistent with the original source data. Only designated individuals at the site will complete the CRFs. The CRFs must be completed at regular intervals following the clinical study visit schedule. It is expected that all data reported have corresponding entries in the source documents. The principal investigator is responsible for reviewing and certifying that the CRFs are accurate and complete. The only subject identifiers recorded on the CRFs will be subject number, and subject demographic information.
Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site monitors are appointed by the Study Sponsor and are independent of study site staff.
Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the eCRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Study monitors are appointed by the Study Sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study.
Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the electronic case report forms (eCRFs) exists and are accessible for verification by the monitor. It is required that the author of each entry in the source documents be identifiable (eg, initials or signature and date). At a minimum, source documents should include the following information for each subject: • Subject identification (name, date of birth or age, sex) • Documentation of subject eligibility • Date of informed consent • Dates of visits • Documentation that protocol-specific procedures were performed • Results of study testing, as required by the protocol • Test article accountability records • Documentation of SAEs and other safety parameters (as applicable) • Records regarding medical histories and the use of concomitant therapies prior to and during the study • Date of study completion and reason for early discontinuation, if applicable Note: If electronic source records are maintained, the method of verification must be determined in advance of starting the study. Direct access to source documentation (medical records) must be allowed for the purpose of verifying that the data recorded on the eCRF are consistent with the original source data. Data reported on the eCRFs shall be derived from source documents and be consistent with these source documents, and any discrepancies shall be explained in writing. Any change or correction to data reported on a source document shall be dated, initialed, and explained if necessary, and shall not obscure the original entry (ie, an audit trail shall be maintained); this applies to both written and electronic changes and corrections. eCRFs shall be signed and dated by the Principal Investigator or his/her authorized designee(s).
Completion of Source Documents and Case Report Forms. The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query resolution process. Site monitors are appointed by the Study Sponsor and are independent of study site staff. If electronic records are maintained, the method of verification must be determined in advance of starting the study. Printed By: Print Date: Alcon - Business Use Only Protocol - Clinical Effective Date: 24-Aug-2017 Document: TDOC-0054027 Status: Effective Version: 1.0; CURRENT; Most-Recent; Effective Page 49 of 52 reported data are accurate, complete, and verifiable from the source documents, and the study is conducted in compliance with the current approved protocol (and amendments[s], if applicable), with current GCP, and with applicable regulatory requirements. The site may not screen subjects or perform the informed consent process on any subject until it receives a notification from an appropriate Study Sponsor representative that the site may commence conducting study activities. Monitoring will be conducted periodically while the clinical study is ongoing. Monitoring methods may include site visits, telephone, written, and fax correspondence. Close-out visits will take place after the last visit of the last subject at the site. A Coordinating Investigator may be identified by the Study Sponsor to review and endorse the final study report. In cases where a Coordinating Investigator is engaged, the Study Sponsor will select the Coordinating Investigator based upon their experience, qualifications, active study participation, and their willingness and availability to take on this role.
