Setting up and Maintaining a Study File

Setting up and maintaining a study file

The Investigators Study File

The Investigators Study File should contain all of the general information that is relevant to the research study. The sponsor often provides a 3-ring binder (or several binders) with tabs to organize all the relevant study documentation. If the sponsor does not provide the binder(s), the investigator or research coordinator should set up a similar system. The Investigator's binder typically includes the following (although the description and order of items in the binder may vary form sponsor to sponsor and/or type of study):

 Protocol and protocol amendments  Investigator's brochure  1572 and/or investigator agreement o This section may also contain the confidentiality agreement (CDA) between the investigator and the sponsor. o This section may also include an insurance or indemnification letter.  CVs and licenses of all key personnel (principal investigator, sub-investigators, research coordinator and other study staff)  Informed consent form o Master copies of the IRB approved versions  Signed individual, original, consent forms are usually filed here and a copy is placed in the subject's medical record. Check your institution's policy for placement of the original signed informed consent form in the subject's medical record.  Adverse drug and device Events (typically IND Safety reports, SAES, AE’s)  Case Report Forms (CRFs)/Data Collection Forms (DCFs) - all versions of a blank set of CRFs/DCFs. o Individual subject CRFs/DCFs are usually filed in a separate binder or folder.  Questionnaires; Surveys; Assessment tools – all versions of a blank set these tools.

 IRB Correspondence o IRB approval letters for: . The protocol . Protocol amendments . Original informed consent form . Amended versions of the informed consent form . Advertisements and other written materials provided to the subjects . Subject compensation (amount and pay-out schedule)  IRB approval for continuation of the study (Continuing Review Forms based on annual or periodic reviews by the IRB)  Notification of new safety information and the IRB recommendations pertaining to this information.

1  Sponsor Correspondence o Written correspondence o Telephone records o Copies of faxes or e-mail correspondence

 Monitoring Log (or site visit log) o Includes documentation of sponsor visits o Sponsor evaluation visit o Study initiation visit o Periodic monitoring visits o Close-out or termination visits  Site personnel signature sheet (you should include a list of personnel responsibilities).  Subject identification code list o This contains a confidential list of the names of all subjects allocated to trial numbers. o This is maintained only at the investigative site, and allows the investigator or institution to reveal the identity of the subject in the case of an emergency.  Subject screening log/Subject enrollment log o This documents the chronological enrollment of subjects  Lab Certification and normal ranges. You may want to include this information in your files if you are using your institution's lab for safety labs) o Include the lab director's CV if appropriate  Study Drug Records o Shipping records: dates, batch numbers, method of shipment o Accountability logs o Randomization code . The sponsor will also provide information on decoding procedures for blinded studies (usually specified in the protocol). Depending on the study, a sealed envelop may be provided to the site, or other provisions will be made for the investigator to contact the sponsor directly in the event of an emergency in which the identification of the study drug must be revealed.  Equipment and supplies (receipt, calibration and maintenance logs)  Specimen Records (if applicable) – Include this section if specimens are stored or shipped as part of the study: o Specimen shipping records – Keep a log of which specimens were shipped, to whom, date of shipment, etc. o Specimen storage records – Keep a log of where specimens are housed by subject study number and date sent to storage. Indicate which study personnel placed the specimen in storage. Specimens should be coded to protect the subject’s identity o Temperature logs – Document temperatures of freezers or refrigerators in which study specimens are housed to indicate that specimens are stored in a stable and appropriate manner.