When a subject is to be enrolled/consented during the time when an amendment to change the consent form has been submitted to the IRB, but the notification of IRB approval has not been received, contact the protocol administrator to check the approval status of the amendment.  Once the amendment is approved, the new version of the consent form supersedes the previous version, and therefore nullifies the previous version.  If the amendment is approved and the IRB notification has been mailed, ask the protocol administrator to fax a copy of the newly approved version, so that the subject will be consented on the appropriate, valid consent form. 

If new investigators/staff are to be added to the study, they should not conduct any study-related activities, such as obtaining informed consent or screening potential subjects, until IRB approval is confirmed or written notification of IRB approval is received.

If a required document is not available at the time of submission (e.g., DSMB meeting is scheduled at a later date), write a cover memo to the IRB, explaining why the required element is missing and indicate that it will be sent immediately to the IRB upon investigator receipt of such report. 

If any violations are identified during preparation for submission, include the violation report along with the CR application. 

If the most recent NIH progress report is dated more than a year ago, write a cover memo to the IRB explaining why a more recent report is unavailable. 

Ensure the protocol and the protocol summary are the most updated versions, incorporating ALL amendments.  Include the version date on each document. 

Ensure that enrollment numbers "match" the race and ethnicity data reported.  If there are any discrepancies, for example, total enrollment number is made up of individuals signing multiple consent forms; explain this in a cover memo to the IRB. 

All subjects who sign a consent form are considered enrolled. If a subject is found to be ineligible, withdraws consent, or is lost to follow-up, they are still counted as enrolled and should be included when reporting enrollment figures to the IRB. 

Do not enroll more subjects than the IRB approved enrollment goal. 

If the study expires before the CR is approved, submit a written request to the IRB to continue research with currently enrolled subjects.  

Maintain an accurate record of shipment and dispensing, including date and amount of study drug or device.  A useful template for recording this information can be found at: http://www.partners.org/phsqi/QIWeb/logs/DrugLog.dot 

Study drug/device must be kept in an appropriate secure area (i.e. locked cabinet), and stored according to conditions specified in the protocol, where only approved study staff have access.

If sponsors do not request this information from you, contact the sponsor and request a written explanation as to why the sponsor has not requested this information or why they are exempt from these reporting requirements. File this documentation in your regulatory binder. 

Provide the required information to the sponsor prior to study start; update the information if there are any changes during the course of the investigation, and for one year after the completion of the trial. Send the original documentation to the sponsor and place a copy in the regulatory binder. 

It is not uncommon for this information to be collected from all individuals listed as study staff.  However, at a minimum for IND studies, all investigators listed on the Form FDA 1572 should provide this information to the sponsor.

All subjects and study representatives must SIGN and DATE the consent form for him/herself. If a subject or PI/study representative fails to date, DO NOT enter date.  Write a signed and dated note to file explaining the consent process and when applicable, report this violation to the IRB. 

Ensure that subject identification is on all pages of the consent form. 

Always give a copy of the signed and dated consent form to the subject and document this practice in each subject's study file or on an enrollment log.

Over-enrollment (more subjects signed the consent form than the IRB approved enrollment goal). 

Unauthorized study representative obtained consent. 

All sponsor approved protocol deviations must also be reported to the IRB.

To ensure that the study file provides an accurate history/timeline of activity from study start to completion, request a copy of any missing IRB correspondence from the protocol administrator. 

All copies of IRB correspondence (e.g. initial review, continuing review, amendment applications, AE reporting, and violation/deviation reports) on file should be copies of the signed and dated submission, and filed in reverse chronological order. 

Notification letters received from the HRC office should have an original signature. 

Double-check all HRC correspondence for accuracy. Contact protocol administrator if an error is found. 

File documents in each subject's file in reverse chronological order. Include any contact with the subject (e.g. correspondence, phone calls, appointment info). 

Maintain correspondences to and from sponsor. 

Where necessary, write a signed and dated note-to-file to clarify errors in record keeping or missing documentation. 

After the study is completed, retain records as required by the institution and sponsor.

Protocol (all versions). 

Signed Form FDA 1571/1572. 

CVs: should be signed, dated, and updated every 2 years.  If filed collectively, write a signed and dated note-to-file indicating where CVs are located. 

Study logs: ensure that all logs contain essential information. 

	Staff Signature: document the signature and initials of all persons collecting and recording study data.
	Delegation of Responsibility: document which study related procedures each study staff member has been delegated by the PI.  The PI should sign and date this documentation, and update it as new staff or study procedures are added.
	Enrollment/screening: capture all subjects who sign a consent form.
	Monitoring: document any form of study monitoring that serves to document the progress of the study, the authenticity and completeness of study data, and ensures that the rights of subjects are being protected.  For example, maintain a copy of meeting minutes, recording at a minimum meeting dates and attendees.
	Drug/device dispensing/accountability

FDA Financial Disclosure Form

Lab Documentation: to document the competency of the lab facility being utilized for a study and to support the reliability of results; maintain copies of normal lab values/ranges, lab certifications (e.g. CLIA, CAP), and a copy of the lab Director's CV.  For missing documentation, write a signed and dated note-to-file, or contact the sponsor or laboratory and request a copy.  Review binders regularly for expiration dates, and request updated copies of lab documentation when necessary. 

Investigator brochure or device manual: where applicable, maintain a copy of the Investigator's brochure, package insert, or device manual.  It is the responsibility of the investigator to read and understand the Investigator Brochure prior to study start.

Ensure that source documentation supporting eligibility is available in the subject's study file and/or medical record. 

Ensure the checklist or documentation of eligibility is signed and dated by the person obtaining the information.

All information entered on a CRF or data collection sheet must be supported by source documents. If data is recorded directly into a CRF there should be at a minimum, an entry in the subject's medical record or subject file that records the date information was obtained; how (e.g. physical exam) and by whom.

Source is wherever data is first recorded (original records or certified copies). Examples of source documents include:

	Hospital records/medical record
	Lab reports
	Subject diaries
	Evaluation checklists
	Pharmacy dispensing records
	X-rays

All CRF/source documents should be completed in ink. Do not use pencil.

Ensure that all CRF/source documents are initialed/signed and dated by the person making an entry, or reviewing and/or validating information the document contains.

Initial and date any cross-out/corrections made in the CRF/source documents. Do not use correction fluid. The correction being made should not obscure the original entry.

A signed and dated note-to-file can be used to explain:

	How information was obtained.
	Who obtained information.
	Any discrepancies.
	Missing or incomplete data.