Concluding A GLP Study

Reports

The study director will analyze and interpret data and prepare a final report for all assigned GLP studies conducted at Texas A&M. Final reports will meet all GLP and Texas A&M requirements. Interim reports, when specified in the study protocol, will adhere to the same requirements. Texas A&M’s QAU will audit final reports prior to issuance to ensure that GLP and Texas A&M requirements are met. The study director will sign final and interim reports. Unless otherwise agreed in advance, Texas A&M will retain the original report or an exact copy and exact copies will be submitted to the QAU and the sponsor.

A Texas A&M report template may be utilized for writing the final report. The Texas A&M template may be modified to suit individual GLP studies, but in no case will required elements be omitted. If the sponsor report template is used, the Texas A&M QAU will audit the template to ensure that it also adheres to the Texas A&M requirements. (Refer to Texas A&M GLP Final Report SOP TAMU-08-001).

When studies are terminated prematurely or discontinued, a final report will be prepared after analyzing and summarizing the data.

GLP interim and final reports must contain the following information at a minimum:

  1. Names and addresses of all facilities involved in conducting the study.
  2. The dates of study initiation and completion.
  3. Objectives and procedures stated in the protocol and any changes in the protocol.
  4. Statistical methods employed for analyzing the data.
  5. The test and control articles identified by name, chemical abstracts number or code. number, strength, purity, and composition or other appropriate characteristics.
  6. Confirmation of stability of the test and control articles under the conditions of administration.
  7. A description of all study methods.
  8. A description of the test system and, where applicable, the number of animals used, sex, body weight range, source of supply, species, strain, substrain, age, and procedures used for identification.
  9. A description of the dosage, dosage regimen, route of administration, and duration of exposure to test and control articles, medications, and therapies.
  10. A description of all circumstances that may have affected the quality or integrity of the data.
  11. The name of the study director, the names of other scientists or professionals, and the names of all supervisory personnel, involved in the study.
  12. A description of the transformations, calculations, statistics or operations performed on the data, a summary and analysis of the data and a statement of the conclusions drawn from the analyses.
  13. The signed and dated reports of each of the individual scientist or other professionals involved in the study.
  14. The locations where all specimens, raw data, and the final report are to be stored.
  15. The quality assurance statement prepared and signed by the QAU.
  16. The final report will be signed and dated by the study director and the sponsor.


Changes to final reports will be issued as amendments. Amendments will clearly identify the part of the final report that is being added to or corrected and the reason for the correction or addition. Amendments will be signed by the study director or contributing scientist responsible for the change and by the sponsor.

Researchers (e.g., pathologists, attending veterinarians, statisticians, engineers) participating in GLP studies as contributing scientists will provide a signed and dated written report to be appended to the final or interim report. The contributing scientist’s reports will include elements specified in the GLP regulations as applicable to the service provided.

Records Storage and Retention Requirements

All raw data, protocols, reports, GLP documentation, quality assurance records, GLP facility records, training records and personnel qualifications, job descriptions, historical and current standard operating procedures, equipment records, and study correspondence will be retained according to the GLP regulations, system regulations, university rules, and standard operating procedures. (Refer to Texas A&M GLP Archiving and Record Retention SOP, Texas A&M University System Policy – Retention and Disposal of Public Records, Texas A&M Rule– Guidelines for Gathering Storage, and Retention of Data and Results, Texas A&M University System Policy– Records Management, and the System Records Retention Schedule)

There will be archives for expedient retrieval and orderly storage of GLP records. Conditions of storage will minimize deterioration of documents, specimens, and other media for the duration of the retention period. Each organizational unit involved in GLP studies will maintain a record and specimen archive or arrange for archiving at approved locations (as applicable). An individual and a backup person will be responsible for the organizational unit’s archive. Access to record and specimen storage areas will be limited to authorized individuals.  If records are transferred to other facilities, the location will be specified in the organizational unit’s archive and in an amended final report.

Food and Drug Administration Inspections

Texas A&M will permit authorized employees of the Food and Drug Administration, at reasonable times, and in a reasonable manner, to inspect the Texas A&M facilities involved in the conduct or support of GLP studies and to inspect records and specimens that are required to be maintained in accordance with the GLP regulations.

Texas A&M will provide copies of records within the scope of the GLP regulations to an authorized employee of the FDA upon request as part of an inspection. FDA representatives will be advised of the confidential nature of GLP study data. Inspection of records and copying requirements will not apply to quality assurance records. Testing facility management will provide written certification of quality assurance inspections upon request.