Various study forms (logs, templates etc.) are being used at Clinical Trial Sites in order to facilitate the conduct of Clinical Trials and to properly document actions taken. All these documents are a part of Investigator Site File (a binder of trial related documentation) and Pharmacy File (a binder of documentation related to Investigational Medicinal Product; mainly used in Clinical Trials where there are blinded and unblinded Site teams with respect to study treatment received by subjects).
Study forms are carefully designed by clinical research project teams during start-up of the Clinical Trial and modified accordingly throughout the trial on ongoing basis as required.
Data collected on the study forms are subject to ongoing review during regular monitoring visits as well as during Site audits and inspections.
This article aims to briefly describe the types and purpose of study forms used at Clinical Trial Sites.
All study forms shall be created and maintained respecting Good Documentation and Good Clinical Practices.
Typical essential elements of each study form are:
- Name of the form
- Clinical Trial information (protocol name and number etc.)
- Site related information (fillable or pre-printed information on Site number, address, Principal Investigator name etc.)
- Properly populated headers and footers (including trial related information, document version and date, pagination)
- Fields to enter information relevant to the purpose of the form
- Date and signature fields, as applicable.
Below are the most common study forms used in Clinical Trials.
Delegation of Authority Log
(other names are: Delegation of Responsibility Log, Site Delegation Log)
Purpose & use: to document Principal Investigator’s delegation of trial related responsibilities to Site study team. Its completion starts at Site Initiation Visit and it is handled on ongoing basis during the trial and is finalised at the Close-out Visit. Information collected on this form is an essential part of Site audit/inspection readiness as it allows to check delegated versus actual performed tasks in Clinical Trial.
Typical information to be collected: defined list of all trial responsibilities, composition of Site study team with full names, study roles (e.g., Principal Investigator, Sub-Investigator, Study Coordinator, Study Nurse, Pharmacist etc.) and assigned responsibilities. Start and stop dates of Site team’s involvement are indicated. Each task delegation and any changes are dated/signed by Principal Investigator and each staff member dates/signs the form as well.
Site Training Log
Purpose & use: to document all performed Site staff training.
Typical information to be collected: training dates, training topics (including the description of training materials used), Trainee and Trainer names, their study roles and corresponding signatures confirming performed training.
Site Visit Log
Purpose & use: to identify type of visit to Clinical Trial Site and document visit attendees. Its completion usually starts at Site Initiation Visit (sometimes it is also used to document Site Selection Visits) and it is handled on ongoing basis during the trial and is finalised at the Close-out Visit.
Typical information to be collected: visit dates, purpose (type) of the visit, names, and signatures of Clinical Research Organisation and/or Sponsor attendees, names, and signatures of Clinical Trial Site attendees.
Source Data Location Log
Purpose & use: to document all types of Source Documents and direct location of their storage. Any changes to location of Source Documents should be documented on a properly amended log.
Typical information to be collected: Source Data category (e.g., Informed Consent Process, Medical History, Laboratory Test results etc.), type of source document (e.g., Informed Consent Form, Study Medical Charts/Diaries, Laboratory Reports etc.), physical location (e.g., Subject Paper Binder, Electronical Medical Records etc.).
Informed Consent (Assent) Form Log
Purpose & use: to document Informed Consent (Assent) Forms used in Clinical Trial and to track their signature by subjects. Usually, this form captures information on Site and Subject levels.
Typical information to be collected:
For Site level: version and date of Informed Consent (Assent) Form, language of ICF, Ethics Committee ICF submission and approval dates, date at which each approved ICF is considered to be implemented at Site.
For Subject level: version and date of Informed Consent (Assent) Form, date of ICF signing by subjects, verification of ICF signature by Clinical Research Associate (date when CRA has checked ICF during monitoring visit).
Subject Pre-Screening Log
Purpose & use: this is an optional log used in the studies where pre-screening (preliminary identification) of subjects is foreseen by the Clinical Trial Protocol. This log is an indicator of Site recruitment efforts even before the first subject is screened in the study.
Typical information to be collected: dates of pre-screening, eligibility of subjects to proceed with selection into the study, reason(s) for pre-screening failure (non-eligibility).
Subject Screening and Enrolment Log
Purpose & use: this is a main form to document subject screening and enrolment.
Typical information to be collected: subject screening dates, subject assigned screening numbers, enrolment (randomisation) dates, eligibility of subjects, reason(s) for screening failure (non-eligibility).
Subject Identification Log
Purpose & use: this form is completed for all subjects that have signed Informed Consent (Assent) Forms and it contains all personal subject information and should never be sent outside the Site nor filed in Trial Master File. This form is exclusively used at Site in order to identify each subject, link them to assigned screening numbers and keep in touch with subjects preventing potential lost to follow-up situations.
Typical information to be collected: subject full name, gender, full date of birth, screening date, screening number, subject’s home address and phone number.
Investigational Medicinal Product (IMP) Accountability Log
Purpose & use: to document the process of assignment, dispensation, and accountability of IMP/Medical Devices, their re-labeling/re-call (if applicable), return and destruction. Concomitant Medications (if provided in the trial) are tracked in the same manner in a separate Concomitant Medication Accountability Log. Usually, this form captures information on Site and Subject levels.
Typical information to be collected:
For Site level: IMP/Medical Device receipt date, kit number, batch number, expiration date, date dispensed to subject, date returned by subject, date returned or destroyed, corresponding verifications of Site staff and CRA.
For Subject level: IMP/Medical Device kit and batch number, date dispensed to subject and quantity of units dispensed, date returned by subject and quantity of units returned, corresponding verifications of Site staff and CRA.
Site Temperature Monitoring Log
Purpose & use: to document temperature storage monitoring of IMP/Medical Devices/Concomitant Medications/laboratory specimens at Site. These logs are maintained and checked on ongoing basis based on corresponding handling manuals. They contain information critical to the safety of subjects as it is important that allowed temperature storage conditions are kept and any excursions are promptly identified, reviewed, and prevented.
Typical information to be collected: temperature monitoring device ID (serial number), storage location, allowed temperature range, refrigerator/freezer IDs, dates of temperature monitoring, temperature measurements on a particular date and time (including actual temperature reading, minimum and maximum temperatures since the last measurement), verification of entries by Site staff.
Biological Specimen Tracking Log
Purpose & use: to document movements of collected samples from Site to Central Laboratory (if applicable). Usually, this form is used to track frozen samples (e.g., for pharmacokinetics analyses) from the moment of their collection at Site and up till the moment they are shipped to designated Central Laboratory.
Typical information to be collected: visit types at which sample collection was performed, sample types (e.g., primary and back-up), date and time of sample collected, dates of sample shipment from Site, courier airway bill tracking number, verification of entries by Site staff.
Serious Adverse Event (SAE) Report Form
Purpose & use: to document details of SAEs occurred at Site from the moment of Site awareness until their “closure” (no more actions required).
Typical information to be collected: date and time of Site awareness of SAE, SAE details (diagnosis if available, start/end dates and times, classification of SAE type as per Good Clinical Practice, subject information, medical and concomitant medication history, event description, study drug information, actions taken as a result of SAE, relationship of SAE to study drug, outcome of SAE etc.), reporting Site staff’s date, time, and signature.
Pregnancy Report Form
Purpose & use: to document the occurrence and outcomes of pregnancy in study subjects or partners of study subjects from the moment of Site awareness until their “closure” (no more actions required).
Typical information to be collected: date and time of Site awareness of pregnancy and its details, medications taken at the time of pregnancy awareness (including study drug), medical history, pregnancy outcome etc.
Carpathian Research Group capabilities
CRG as a CRO has supported multiple Sponsors in creation and review of various study forms. We can utilise our profound expertise in order to create/review any specific study form tailored to the Sponsor’s trial related needs.
Information on all other Clinical Trial services that we provide could be found at www.crg.global
You can contact us at firstname.lastname@example.org